CLASS II ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report

Medtronic Accelerate Grafton Dbf a) Accelerate BG Set recalled

Medtronic Sofamor Danek USA is recalling Medtronic Accelerate Grafton Dbf a) Accelerate BG Set T50203 Grafton Dbf 3CC, distributed nationwide in the US. The recall was initiated on 8 Feb 2023 and the FDA has classified it as Class II.

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Lot, batch or date codesa) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012, A45206-013, A45206-014, A45206-016, A45206-018, A45206-019, A45206-020, A45206-021, A45206-022, A45206-023, A45206-024, A45206-025, A45206-026, A45206-027, A45206-028, A45206-029, A45206-030, A45206-031, A45206-032, A45206-033, A45206-034, A45206-035, A45206-036, A45206-037, A45206-038, A45206-040, A45206-041, A45206-042, A45206-043, A45206-045, A45206-046, A45206-047, A45206-048, A45206-049, A45206-050, A45206-051, A45206-052, A45206-053, A45206-054, A45206-055, A45206-056, A45206-057, A45206-058, A45206-061, A45206-063, A45206-064, A45206-066, A45206-067, A45206-068, A45206-069, A45206-070, A45206-071, A45206-072, A45489-011, A45489-012, A45489-015, A45489-016, A45489-017, A45489-021, A45489-022, A45489-023, A45489-024, A45489-025, A45489-026, A45489-027, A45489-028, A45489-030, A45489-032, A45489-036, A45489-037, A45489-038, A45489-039, A45489-040, A45489-041, A45489-042, A45489-045, A45489-046, A45489-047, A45489-048, A45489-049, A45489-050, A45489-051, A45870-011, A45870-012, A45870-013, A45870-014, A45870-015, A45870-016, A45870-017, A45870-018, A45870-019, A45870-020, A45870-021, A45870-022, A45870-023, A45870-025, A45870-026, A45870-027, A45870-032, A45870-033, A45870-036, A45870-038, A45870-039, A45870-040, A45870-041, A45870-042, A45870-043, A45870-044, A45870-045, A45870-046, A45870-047, A46716-036, A46716-037, A46716-038, A46716-039, A46716-040, A46716-041, A46716-042, A46716-044, A46716-046, A46716-047, A46716-048, A46716-051, A46716-054, A46716-055, A46716-056, A46716-057, A46716-058, A46716-060, A46716-061, A46716-062, A46716-065, A46716-066, A46716-067, A46716-069, A46716-070, A46716-071, A46716-072, A46716-073, A46716-074, A46716-075, A46716-076, A46716-080, A46716-081, A46716-082, A46716-083, A46716-084, A46716-085, A46716-086, A46716-087, A46716-088, A46716-089, A46716-090, A46716-091, A46716-092, A46716-093, A46716-094, A46716-095, A46716-096, A46716-107, A48729-045, A49241-011, A49241-012, A49241-013, A49241-014, A49241-016, A49241-017, A49241-018, A49241-019, A49241-020, A49241-021, A49241-022, A49241-023, A49241-024, A49241-025, A49241-026, A49241-027, A49241-028, A49241-029, A49241-030, A49241-031, A49241-032, A49241-033, A49241-034, A49241-035, A49241-036, A49241-037, A49241-038, A49241-039, A49241-040, A49241-041, A49241-042, A49241-043, A49241-044, A49241-045, A49241-046, A49241-047, A49241-048, A49241-049, A49241-050, A49241-051, A49241-052, A49241-053, A49241-054, A49241-055, A49241-056, A49241-057, A49241-058, A49241-059, A49241-060, A49241-061, A49241-062, A49241-063, A49241-064, A49241-065, A49241-067, A49241-068, A49241-069, A49241-070, A49241-071, A49241-072, A49241-073, A49241-074, A49241-076, A49241-078, A49241-079, A49241-080, A49241-081, A49241-082, A49241-083, A49241-084, A49241-086, A49241-088, A49241-089, A49241-090, A49241-091, A49241-093, A49241-095, A49241-096, A49241-098, A49241-099, A49241-100, A49241-101, A49241-102, A49241-103, A49241-104, A49241-105, A49555-011, A49555-012, A49555-013, A49555-014, A49555-022, A49555-024, A49555-026, A49555-027, A49555-028, A49555-029, A49555-030, A49555-031, A49555-032, A49555-035, A49818-011, A49818-012, A49818-013, A49818-014, A49818-015, A49818-016, A49818-017, A49818-018, A49818-020, A49818-022, A49818-023, A49818-025, A49818-026, A49818-027, A49818-028, A49818-029, A49818-030, A49818-031, A49818-032, A49818-034, A49818-035, A49818-036, A49818-037, A49818-038, A49818-039, A49818-040, A49818-041, A49818-042, A49818-043, A49818-044, A49818-045, A49818-048, A49818-049, A49818-050, A49818-051, A49818-052, A49818-053, A49818-054, A49818-055, A49818-056, A49818-057, A49818-058, A49818-059, A49818-060, A49818-061, A49818-062, A49818-063, A49818-064, A49818-065, A49818-066, A49818-067, A49818-068, A49818-069, A49818-071, A49818-072, A49818-073, A49818-074, A49818-075, A49818-076, A49818-077, A49818-079, A49818-080, A49818-081, A49818-082, A49818-083, A49818-084, A49818-085, A49818-086, A49818-087, A49818-088, A49818-089, A49818-090, A49818-091, A49818-092, A49818-093, A49818-094, A49818-095, A49818-096, A49818-097, A49818-098, A49818-099, A49818-100, A49818-101, A50197-011, A50197-014, A50197-015, A50197-017, A50197-018, A50197-019, A50197-020, A50197-021, A50197-022, A50197-024, A50197-025, A50197-026, A50197-027, A50197-028, A50197-029, A50197-030, A50197-031, A50197-032, A50197-033, A50197-034, A50197-035, A50197-036, A50197-037, A50197-038, A50197-039, A50197-040, A50197-041, A50197-042, A50197-043, A50197-047, A50197-048, A50197-049, A50197-050, A50197-051, A50197-052, A50197-053, A50197-054, A50197-055, A50197-056, A50197-057, A50197-058, A50197-059, A50197-060, A50197-061, A50197-062, A50197-063, A50197-064, A50197-065, A50197-066, A50197-067, A50197-068, A50197-069, A50197-070, A50197-071, A50197-072, A50197-073, A50197-074, A50197-075, A50197-076, A50197-077, A50197-078, A50197-079; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206, GTIN 00763000244712, Serial Numbers: A42287-087, A42287-088, A42287-089, A42287-090, A42287-092, A42287-093, A42287-094, A42287-095, A42287-100, A42287-101, A42287-102, A42287-103, A42287-104, A42287-105, A42287-108, A42287-112, A42287-113, A42287-114, A42287-116, A42287-117, A42287-118, A42287-119, A42287-121, A42287-122, A42287-123, A42287-124, A42287-125, A42287-126, A42287-160, A42287-161, A42287-162, A42287-163, A42287-164, A42287-165, A42287-166, A42287-167, A45179-026, A45179-027, A45179-028, A45179-029, A45179-030, A45179-031, A45179-032, A45179-033, A45179-034, A45179-036, A45179-037, A45179-038, A45179-039, A45179-040, A45179-041, A45179-042, A45179-043, A45179-044, A45179-045, A45179-046, A45179-047, A45179-048, A45179-051, A45179-052, A45179-054, A45179-055, A45179-056, A45179-057, A45179-058, A45179-059, A45179-060, A45179-061, A45179-062, A45179-063, A45179-064, A45492-013, A45492-014, A45492-015, A45492-016, A45492-017, A45492-019, A45492-020, A45492-023, A45492-024, A45492-025, A45492-026, A45492-027, A45492-028, A45492-029, A45492-031, A45492-032, A45492-033, A45492-038, A45492-039, A45492-040, A45492-041, A45492-042, A45492-043, A45492-045, A45492-046, A45492-047, A45492-048, A45492-049, A45492-050, A45492-051, A45492-052, A45492-053, A45492-054, A45492-057, A45492-058, A45492-060, A45492-062, A45492-063, A45492-064, A45492-065, A45492-066, A45492-068, A45492-070, A45492-071, A45492-072, A45492-073, A45492-074, A45492-075, A45492-076, A45492-077, A45492-078, A45492-079, A45492-080, A45492-081, A45492-084, A45492-085, A45492-086, A45492-091, A45492-092, A45492-096, A45492-097, A45492-098, A45492-099, A46669-025, A46669-028, A46669-035, A46669-037, A46669-043, A46669-044, A47321-011, A47321-012, A47321-013, A47321-014, A47321-015, A47321-016, A47321-017, A47321-018, A47321-019, A47321-020, A47321-021, A47321-022, A47321-023, A47321-024, A47321-025, A47321-026, A47321-027, A47321-028, A47321-029, A47321-030, A47321-031, A47321-032, A47321-033, A47321-034, A47321-035, A47321-036, A47321-037, A47321-038, A47321-039, A47321-040, A47321-041, A47321-042, A47321-043, A47321-044, A48003-011, A48003-012, A48003-013, A48003-014, A48003-015, A48003-016, A48003-017, A48003-018, A48003-019, A48003-020, A48003-021, A48003-022, A48003-023, A48003-024, A48003-025, A48003-026, A48003-027, A48003-028, A48003-029, A48003-030, A48003-031, A48003-032, A48003-033, A48003-034, A48003-035, A48003-036, A48003-037, A48003-039, A48003-040, A48003-041, A48003-042, A48003-043, A48003-044, A48003-045, A48003-046, A48003-047, A48003-048, A48003-049, A48003-050, A48003-051, A48003-052, A48003-053, A48003-054, A48003-055, A48003-056, A48003-057, A48003-058, A48003-059, A48003-060, A48003-061, A48003-062, A48003-063, A48003-064, A48003-065, A48003-066, A48003-067, A48003-068, A48003-069, A48003-070, A48003-071, A48003-072, A48003-073, A48003-074, A48003-075, A48003-076, A48003-077, A48003-078, A48003-079, A48003-080, A48174-012, A48174-015, A48174-016, A48174-017, A48174-018, A48174-019, A48174-020, A48174-021, A48174-022, A48174-023, A48174-024, A48174-025, A48174-026, A48174-027, A48174-028, A48174-029, A48174-030, A48174-031, A48174-032, A48174-033, A48174-034, A48174-035, A48174-036, A48174-037, A48174-038, A48174-039, A48174-041, A48174-042, A48174-043, A48174-044, A48174-045, A48174-046, A48174-047, A48174-051, A48174-054, A48174-057, A48174-058, A48174-059, A48174-060, A48174-061, A48174-062, A48174-063, A48174-064, A48174-065, A48174-066, A48174-067, A48174-068, A48174-069, A48174-070, A48174-071, A48174-072, A48174-073, A48174-074, A48174-075, A48174-076, A48174-077, A48174-078, A48174-079, A48174-080, A48174-081, A48174-082, A48174-083, A48174-084, A48174-085, A48174-086, A48174-087, A48174-088, A48174-089, A48174-090, A48174-092, A48174-093, A48174-094, A48174-095, A48174-096, A48174-097, A48174-098, A48174-099, A48174-100, A48174-101, A48174-102, A48174-103, A48174-104, A48174-105, A48174-106, A48174-107, A48174-108, A48286-016, A48286-017, A48286-018, A48286-019, A48286-020, A48286-021, A48286-022, A48286-023, A48286-024, A48286-025, A48286-026, A48286-027, A48286-028, A48286-029, A48286-030, A48286-031, A48286-032, A48286-033, A48286-034, A48286-035, A48286-036, A48286-037, A48286-038, A48286-039, A48286-040, A48286-041, A48286-042, A48286-043, A48286-044, A48286-045, A48286-046, A48286-047, A48286-048, A48286-049, A48286-050, A48286-051, A48286-052, A48286-053, A48286-054, A48286-055, A48286-056, A48286-057, A48286-058, A48286-059, A48286-060, A48286-061, A48286-062, A48286-063, A48286-064, A48286-065, A48286-066, A48286-067, A48286-068, A48286-069, A48286-070, A48286-071, A48286-072, A48286-073, A48286-074, A48286-075, A48286-076, A48286-077, A48286-078, A48286-079, A48286-080, A48286-081, A48286-082, A48286-083, A48286-084, A48286-085, A48286-086, A48286-087, A48286-088, A48286-089, A48286-090, A48286-092, A48286-093, A48286-094, A48286-095, A48286-096, A48286-097, A48286-098, A48286-099, A48286-100, A48286-101, A48286-102, A48286-103, A48286-104, A48286-105, A48286-106, A48286-107, A48286-108, A48286-109, A48286-110, A48286-111, A48286-112, A48286-113, A48286-114, A48286-115, A48286-116, A48286-117, A48286-118, A48286-119, A48286-120, A48286-121, A48286-122, A48286-123, A48967-011, A48967-012, A48967-013, A48967-014, A48967-015, A48967-016, A48967-017, A48967-018, A48967-019, A48967-020, A48967-021, A48967-022, A48967-023, A48967-024, A48967-025, A48967-026, A48967-027, A48967-028, A48967-029, A48967-030, A48967-031, A48967-032, A48967-033, A48967-034, A48967-035, A48967-036, A48967-037, A48967-038, A48967-039, A48967-040, A48967-042, A48967-043, A48967-044, A48967-045, A48967-046, A48967-047, A48967-048, A48967-049, A48967-050, A48967-051, A48967-052, A48967-053, A48967-054, A48967-055, A48967-056, A48967-057, A48967-058, A48967-059, A48967-060, A48967-062, A48967-063, A48967-064, A48967-065, A48967-066, A48967-067, A48967-068, A48967-069, A48967-070, A48967-071, A48967-072, A48967-073, A48967-074, A48967-075, A48967-076, A48967-077, A48967-078, A48967-079, A48967-080, A48967-081, A48967-082, A48967-083, A48967-084, A48967-085, A48967-086, A48967-087, A48967-088, A48967-089, A48967-090, A49028-081, A49028-082, A49028-083, A49028-084, A49028-085, A49028-086, A49028-087, A49028-088, A49028-089, A49028-090, A49028-091, A49028-092, A49028-093, A49028-094, A49028-095, A49028-096, A49028-097, A49028-098, A49028-102, A49028-103, A49028-104, A49028-105, A49028-106, A49028-107, A49028-108, A49028-109, A49028-110, A49028-111, A49028-112, A49028-113, A49028-114, A49075-011, A49075-013, A49075-014, A49075-015, A49075-016, A49075-017, A49075-018, A49075-019, A49075-020, A49075-021, A49075-022, A49075-023, A49075-026, A49075-027, A49075-030, A49075-031, A49075-032, A49075-033, A49075-034, A49075-035, A49075-036, A49075-037, A49075-039, A49075-040, A49075-041, A49075-042, A49075-043, A49075-044, A49075-045, A49075-046, A49075-047, A49075-048, A49075-049, A49075-053, A49075-054, A49075-055, A49075-056, A49075-057, A49075-058, A49075-059, A49075-060, A49075-061, A49075-062, A49075-063, A49125-011, A49125-012, A49125-014, A49125-015, A49125-016, A49125-017, A49125-018, A49125-019, A49125-024, A49125-025, A49125-026, A49125-027, A49125-031, A49125-036, A49125-037, A49125-040, A49125-041, A49125-042, A49125-043, A49125-044, A49125-045, A49125-046, A49125-049, A49125-050, A49125-051, A49125-052, A49125-053, A49125-054, A49125-055, A49125-056, A49125-057, A49125-058, A49125-059, A49125-060, A49125-061, A49125-062, A49125-063, A49125-064, A49125-065, A49125-066, A49125-069, A49125-070, A49125-071, A49125-072, A49125-073, A49125-074, A49125-075, A49125-076, A49125-077, A49125-078, A49125-079, A49125-080, A49125-083, A49125-084, A49125-085, A49125-086, A49125-087, A49125-088, A49125-089, A49125-090, A49125-091, A49125-092, A49125-093, A49125-094, A49125-095, A49125-096, A49125-097, A49125-098, A49125-099, A49125-100, A49125-101, A49125-102, A49125-103, A49125-104, A49125-105, A49125-106, A49125-107, A49125-110, A49125-111, A49125-112, A49125-113, A49125-114, A49125-115, A49125-116, A49125-117, A49176-011, A49176-012, A49176-013, A49176-014, A49176-015, A49176-016, A49176-017, A49176-018, A49176-019, A49176-020, A49176-021, A49176-022, A49176-023, A49176-028, A49176-030, A49176-031, A49176-032, A49176-033, A49176-034, A49176-035, A49176-036, A49176-037, A49176-038, A49176-039, A49176-040, A49176-041, A49176-042, A49176-043, A49176-044, A49176-045, A49176-046, A49176-047, A49176-048, A49176-049, A49176-050, A49176-051, A49176-052, A49176-053, A49176-054, A49176-055, A49176-056, A49176-057, A49176-058, A49240-011, A49240-012, A49240-013, A49240-014, A49240-015, A49240-016, A49240-017, A49240-018, A49240-019, A49240-020, A49240-021, A49240-022, A49240-023, A49240-024, A49240-025, A49240-026, A49240-027, A49240-028, A49240-029, A49240-030, A49240-031, A49240-032, A49240-033, A49240-034, A49240-035, A49240-036, A49240-037, A49240-038, A49240-039, A49240-040, A49240-041, A49240-042, A49240-043, A49240-044, A49240-045, A49240-046, A49240-047, A49240-048, A49240-049, A49240-050, A49240-051, A49240-052, A49240-053, A49240-054, A49240-055, A49240-056, A49240-057, A49240-058, A49240-059, A49240-060, A49240-061, A49240-062, A49240-063, A49240-064, A49240-065, A49240-066, A49240-067, A49240-068, A49240-069, A49240-070, A49240-071, A49240-072, A49240-073, A49240-074, A49240-075, A49240-076, A49265-011, A49265-012, A49265-013, A49265-014, A49265-015, A49265-016, A49265-017, A49265-018, A49265-019, A49265-020, A49265-021, A49265-022, A49265-023, A49265-024, A49265-025, A49265-026, A49265-027, A49265-028, A49265-029, A49265-030, A49265-031, A49265-032, A49265-033, A49265-034, A49265-035, A49265-036, A49265-037, A49265-038, A49265-039, A49265-040, A49265-041, A49265-042, A49265-043, A49265-044, A49265-045, A49265-046, A49265-047, A49265-048, A49265-049, A49265-050, A49265-051, A49265-052, A49265-053, A49265-054, A49265-055, A49265-056, A49265-057, A49265-058, A49265-059, A49265-060, A49265-061, A49265-062, A49265-063, A49265-064, A49265-065, A49265-066, A49265-067, A49265-068, A49265-069, A49265-070, A49265-074, A49265-075, A49265-076, A49265-077, A49265-078, A49265-079, A49265-080, A49265-081, A49265-082, A49265-083, A49265-084, A49265-085, A49265-086, A49265-088, A49265-089, A49265-090, A49265-091, A49265-092, A49265-093, A49265-094, A49265-095, A49265-096, A49265-097, A49265-098, A49265-099, A49265-100, A49265-101, A49265-102, A49265-103, A49265-104, A49265-105, A49265-106, A49265-107, A49265-108, A49265-109, A49265-110, A49265-111, A49265-112, A49265-113, A49265-115, A49308-011, A49308-012, A49308-013, A49308-014, A49308-015, A49308-016, A49308-017, A49308-021, A49308-022, A49308-023, A49308-024, A49308-025, A49308-026, A49308-027, A49308-028, A49308-029, A49308-030, A49308-031, A49308-032, A49308-033, 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A49372-012, A49372-013, A49372-014, A49372-015, A49372-016, A49372-017, A49372-018, A49372-019, A49372-020, A49372-021, A49372-022, A49372-023, A49372-024, A49372-025, A49372-026, A49372-027, A49372-028, A49372-029, A49372-030, A49372-031, A49372-032, A49372-033, A49372-034, A49372-035, A49372-036, A49372-037, A49372-038, A49372-039, A49372-040, A49372-041, A49372-042, A49372-043, A49372-044, A49372-045, A49372-046, A49372-048, A49372-052, A49372-053, A49372-054, A49372-057, A49372-058, A49372-059, A49372-060, A49372-061, A49372-062, A49372-063, A49372-064, A49372-065, A49372-066, A49372-067, A49372-068, A49372-069, A49372-070, A49372-071, A49372-072, A49372-073, A49372-074, A49372-075, A49372-076, A49488-011, A49488-012, A49488-013, A49488-014, A49488-015, A49488-016, A49488-017, A49488-018, A49488-019, A49488-020, A49488-022, A49488-023, A49488-024, A49488-025, A49488-026, A49488-027, A49488-028, A49488-029, A49488-030, A49488-031, A49488-032, A49488-033, A49488-034, A49488-035, A49488-036, A49488-037, A49488-038, A49488-039, A49488-040, A49488-042, A49488-043, A49488-044, A49488-045, A49488-046, A49488-047, A49488-048, A49488-049, A49488-050, A49488-051, A49488-052, A49488-053, A49488-054, A49488-055, A49488-056, A49488-057, A49488-058, A49488-059, A49488-060, A49488-061, A49488-062, A49488-063, A49488-064, A49488-065, A49488-066, A49488-069, A49488-070, A49488-071, A49488-072, A49488-073, A49488-074, A49488-075, A49488-076, A49488-077, A49492-011, A49492-012, A49492-013, A49492-014, A49492-015, A49492-016, A49492-017, A49492-018, A49492-019, A49492-020, A49492-021, A49492-022, A49492-023, A49492-024, A49492-025, A49492-026, A49492-028, A49492-029, A49492-030, A49492-031, A49492-032, A49492-033, A49492-034, A49492-035, A49492-036, A49492-037, A49492-038, A49492-039, A49492-040, A49492-041, A49492-042, A49492-043, A49492-044, A49492-045, A49492-046, A49492-047, A49492-048, A49492-049, A49492-050, A49492-051, A49492-052, A49492-054, A49492-055, A49492-056, A49492-057, A49492-058, A49492-059, A49492-060, A49492-061, A49492-062, A49492-063, A49492-064, A49492-065, A49492-066, A49492-067, A49492-068, A49492-069, A49492-070, A49492-071, A49492-072, A49492-073, A49492-074, A49492-075, A49492-076, A49492-077, A49492-078, A49492-079, A49492-080, A49549-012, A49549-013, A49549-014, A49549-015, A49549-016, A49549-030, A49549-037, A49549-039, A49549-040, A49549-041, A49549-042, A49549-043, A49549-044, A49549-045, A49549-046, A49549-047, A49549-048, A49549-092, A49549-102, A49665-011, A49665-012, A49665-013, A49665-014, A49665-015, A49665-016, A49665-017, A49665-018, A49665-019, A49665-020, A49665-021, A49665-022, A49665-023, A49665-024, A49665-025, A49665-026, A49665-028, A49665-029, A49665-034, A49665-035, A49665-036, A49665-037, A49665-038, A49665-039, A49665-040, A49665-043, A49665-044, A49665-045, A49665-046, A49665-047, A49665-048, A49665-049, A49665-050, A49665-051, A49665-052, A49665-053, A49665-056, A49665-058, A49665-059, A49665-061, A49665-062, A49665-063, A49665-064, A49665-065, A49665-066, A49665-067, A49665-068, A49665-069, A49665-070, A49665-071, A49665-072, A49665-073, A49665-074, A49665-075, A49665-076, A49665-077, A49665-078, A49665-079, A49665-080, A49665-081, A49665-082, A49665-083, A49665-084, A49665-085, A49822-012, A49822-013, A49822-014, A49822-015, A49822-016, A49822-017, A49822-018, A49822-019, A49822-021, A49822-022, A49822-023, A49822-024, A49822-027, A49822-028, A49822-029, A49822-030, A49822-031, A49822-032, A49822-033, A49822-034, A49822-035, A49822-036, A49822-037, A49822-038, A49822-039, A49822-040, A49822-041, A49822-042, A49822-043, A49822-044, A49822-045, A49822-046, A49822-047, A49822-048, A49822-049, A49822-050, A49822-052, A49822-054, A49822-055, A49822-056, A49822-057, A49822-058, A49822-059, A49822-061, A49822-062, A49822-063, A49822-064, A49822-065, A49822-066, A49822-067, A49822-068, A49822-069, A49822-070, A49822-071, A49822-072, A49822-073, A49822-074, A49822-075, A49822-076, A49822-077, A49822-078, A49822-079, A49822-080, A50132-011, A50132-012, A50132-013, A50132-014, A50132-015, A50132-016, A50132-017, A50132-018, A50132-019, A50132-020, A50132-021, A50132-022, A50132-023, A50132-024, A50132-025, A50132-026, A50132-027, A50132-028, A50132-029, A50132-030, A50132-031, A50132-032, A50132-033, A50132-034, A50132-035, A50132-036, A50132-037, A50132-038, A50132-039, A50132-040, A50132-041, A50132-042, A50132-043, A50132-044, A50132-045, A50132-046, A50132-047, A50132-048, A50132-049, A50132-050, A50132-051, A50132-052, A50132-053, A50132-054, A50132-055, A50132-056, A50132-057, A50132-058, A50132-059, A50132-060, A50132-061, A50132-062, A50132-063, A50132-064, A50132-065, A50132-066, A50132-067, A50132-068, A50132-069, A50132-070, A50132-071, A50132-072, A50132-073, A50132-074, A50132-075, A50132-076, A50132-077, A50132-078, A50132-079, A50132-080, A50132-081, A50132-082, A50132-083, A50132-084, A50132-085, A50132-086, A50132-087, A50132-088, A50132-089, A50132-090, A50132-091, A50132-092, A50132-093, A50132-094, A50132-095, A50132-096, A50132-097, A50132-098, A50132-099, A50132-100, A50132-101, A50224-011, A50224-012, A50224-013, A50224-014, A50224-015, A50224-016, A50224-019, A50224-020, A50224-021, A50224-022, A50224-023, A50224-024, A50224-025, A50224-026, A50224-027, A50224-028, A50224-029, A50224-030, A50224-031, A50224-032, A50224-033, A50224-034, A50224-035, A50224-036, A50224-037, A50224-038, A50224-039, A50224-040, A50224-042, A50224-043, A50224-044, A50224-045, A50224-046, A50224-047, A50224-048, A50224-049, A50224-053, A50224-054, A50224-055, A50224-056, A50224-057, A50224-058, A50224-059, A50224-060, A50224-061, A50224-062, A50224-063, A50224-064, A50224-065, A50224-066, A50224-067, A50224-068, A50224-069, A50224-070, A50299-011, A50299-012, A50299-013, A50299-014, A50299-015, A50299-016, A50299-017, A50299-018, A50299-019, A50299-020, A50299-023, A50299-024, A50299-025, A50299-026, A50299-027, A50299-028, A50299-029, A50299-030, A50299-031, A50299-033, A50299-034, A50299-037, A50299-038, A50299-039, A50299-040, A50299-041, A50299-042, A50299-043, A50299-044, A50299-045, A50299-046, A50299-047, A50299-048, A50299-049, A50299-050, A50299-051, A50299-052, A50299-053, A50299-054, A50299-055, A50299-056, A50299-057, A50299-058, A50299-059, A50299-060, A50299-061, A50299-065, A50299-067, A50299-068, A50299-069, A50299-070, A50299-071, A50299-072, A50299-073, A50299-074, A50299-075, A50299-076, A50299-077, A50299-078, A50299-079, A50299-080, A50299-081, A50299-082, A50299-083, A50299-084, A50299-085, A50299-086, A50299-087, A50299-088, A50299-089, A50299-090, A50299-091, A50299-092, A50299-093, A50299-094, A50299-095, A50299-096, A50299-097, A50299-098, A50299-099, A50299-100, A50299-101, A50784-029, A50784-030; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209, GTIN 00763000244729, Serial Numbers: A45398-036, A45398-037, A45398-038, A45398-039, A45398-040, A45398-041, A45398-042, A45398-043, A45398-044, A45398-045, A45398-046, A45398-047, A45398-048, A45398-049, A46088-011, A46088-012, A46088-013, A46088-014, A46088-015, A46088-016, A46088-017, A46088-018, A46088-019, A46088-020, A46088-021, A46088-022, A46088-023, A46088-024, A46088-025, A46088-026, A46088-027, A46088-029, A46088-030, A46088-031, A46088-032, A46088-033, A46088-034, A46088-035, A46088-036, A46088-037, A46088-038, A46088-039, A46088-040, A46088-042, A46088-043, A46088-044, A46088-045, A46948-011, A46948-012, A46948-015, A46948-017, A46948-018, A46948-019, A46948-020, A46948-021, A46948-022, A46948-023, A46948-026, A46948-027, A46948-028, A46948-029, A46948-030, A46948-031, A46948-032, A46948-033, A46948-034, A46948-039, A46948-040, A46948-041, A46948-042, A46948-043, A46948-044, A46948-046, A46948-047, A46948-048, A46948-049, A46948-051, A46948-053, A46948-054, A48537-048, A48537-049, A48537-050, A48537-051, A48537-052, A48537-053, A48537-054, A48537-055, A48537-056, A48537-057, A48537-058, A48537-059, A48537-060, A48537-061, A48537-062, A48537-063, A48537-064, A48537-065, A48537-066, A48537-067, A48537-068, A48537-069, A48537-072, A48537-073, A48537-074, A48537-075, A48537-076, A48537-077, A48537-078, A48537-079, A48537-082, A49119-011, A49119-012, A49119-013, A49119-014, A49119-015, A49119-016, A49119-017, A49119-018, A49119-019, A49119-020, A49119-021, A49119-022, A49119-023, A49119-024, A49119-025, A49119-026, A49119-027, A49119-028, A49119-029, A49119-030, A49119-031, A49119-032, A49119-033, A49119-035, A49119-036, A49119-038, A49119-039, A49119-040, A49119-042, A49119-043, A49119-044, A49119-045, A49119-046, A49119-047, A49119-048, A49119-049, A49119-050, A49409-011, A49409-012, A49409-013, A49409-014, A49409-015, A49409-016, A49409-017, A49409-018, A49409-019, A49409-020, A49409-021, A49409-022, A49409-023, A49409-024, A49409-025, A49409-026, A49409-027, A49409-028, A49409-029, A49409-030, A49409-031, A49409-033, A49409-034, A49409-035, A49409-036, A49409-037, A49409-038, A49409-039, A49409-041, A49409-042, A49409-043, A49409-044, A49409-045, A49409-046, A49409-047, A49409-048, A49409-049, A49409-050, A49409-051, A49409-052, A49409-053, A49409-054, A49409-055, A49409-056, A49409-057, A49409-058, A49409-059, A49554-011, A49554-012, A49554-013, A49554-014, A49554-015, A49554-020, A49554-021, A49554-022, A49554-023, A49554-024, A49554-025, A49554-026, A49554-027, A49554-028, A49554-029, A49554-030, A49554-031, A49554-032, A49554-033, A49554-034, A49554-036, A49554-037, A49554-038, A49554-039, A49554-040, A49554-041, A49554-042, A49554-043, A49554-044, A49554-045, A49554-046, A49554-047, A49554-048, A49554-050, A49554-051, A49554-052, A49554-053, A49554-054, A49554-055, A49554-056, A49554-057, A49554-058, A49554-059, A49554-060, A49554-063, A49554-065, A49554-066, A49606-011, A49606-012, A49606-013, A49606-014, A49606-015, A49606-016, A49606-017, A49606-020, A49606-021, A49606-022, A49606-023, A49606-024, A49606-025, A49606-026, A49606-027, A49606-028, A49606-029, A49606-030, A49606-032, A49606-033, A49606-034, A49606-035, A49606-036, A49606-037, A49606-038, A49606-039, A49606-040, A49606-041, A49606-042, A49606-043, A49606-044, A49606-045, A49606-046, A49606-047, A49606-048, A49606-049, A49606-050, A49606-051, A49606-052, A49606-053, A49606-055, A49606-056, A49606-058, A49606-059, A49606-060, A49606-061, A49606-065, A49606-066, A49606-067, A49606-069, A49606-070, A49652-012, A49652-018, A49652-019, A49652-021, A49652-022, A49652-023, A49652-024, A49652-025, A49652-026, A49652-027, A49652-028, A49652-029, A49652-032, A49652-033, A49652-034, A49652-035, A49652-036, A49652-037, A49652-038, A49652-039, A49652-040, A49652-041, A49652-042, A49652-043, A49652-044, A49652-045, A49652-046, A49652-047, A49652-048, A49652-049, A49652-051, A49652-052, A49652-053, A49652-055, A49652-056, A49652-057, A49652-058, A49652-059, A49652-060, A49652-061, A49652-062, A49652-063, A49652-064, A49652-065, A49652-066, A49707-036, A49707-037, A49707-038, A49707-039, A49707-041, A49707-042, A49707-045, A49707-046, A49707-047, A49707-048, A49707-049, A49707-050, A49707-051, A49707-052, A49707-053, A49707-054, A49707-055, A49707-056, A49707-057, A49707-058, A49707-059, A49707-060, A49707-061, A49707-062, A49707-063, A49810-011, A49810-012, A49810-013, A49810-014, A49810-015, A49810-016, A49810-017, A49810-018, A49810-019, A49810-021, A49810-023, A49810-026, A49810-027, A49810-028, A49810-029, A49810-030, A49810-031, A49810-032, A49810-033, A49810-034, A49810-036, A49810-038, A49810-040, A49810-041, A50025-012, A50025-013, A50025-014, A50025-015, A50025-016, A50025-017, A50025-018, A50025-019, A50025-020, A50025-021, A50025-022, A50025-023, A50025-024, A50025-025, A50025-026, A50025-027, A50025-029, A50025-030, A50025-031, A50025-032, A50025-033, A50025-034, A50025-035, A50025-036, A50025-037, A50025-038, A50025-039, A50025-040, A50025-041, A50025-042, A50025-043, A50025-044, A50025-045, A50025-046, A50025-047, A50025-048, A50025-049, A50025-050, A50025-051, A50025-052, A50025-053, A50025-054, A50025-055, A50025-056, A50025-057, A50025-058, A50025-059, A50025-060, A50025-061, A50473-011, A50473-012, A50473-013, A50473-014, A50473-015, A50473-016, A50473-017, A50473-018, A50473-019, A50473-020, A50473-021, A50473-022, A50473-023, A50473-024, A50473-025, A50473-026, A50473-027, A50473-028, A50473-029, A50473-030, A50473-031, A50473-032, A50473-033, A50473-034, A50473-035, A50473-036, A50473-037, A50473-038, A50473-039, A50473-040, A50473-041, A50473-042, A50473-043, A50473-044, A50473-045, A50473-046, A50473-047, A50574-011, A50574-012, A50574-013, A50574-014, A50574-015, A50574-028, A50574-029, A50574-030, A50574-031, A50574-032, A50574-033, A50574-034, A50574-035, A50574-036, A50574-037, A50574-038, A50574-039, A50574-041, A50574-042, A50574-043, A50574-044, A50574-045, A50574-046, A50574-047, A50574-048, A50574-049, A50574-050, A50574-051, A50574-052, A50574-053, A50574-054, A50574-055, A50574-056, A50574-057, A50574-058, A50574-059, A50584-011, A50584-012, A50584-013, A50584-014, A50584-015, A50584-017, A50584-018, A50584-019, A50584-020, A50584-021, A50584-022, A50584-023, A50584-024, A50584-025, A50584-026, A50584-027, A50584-028, A50584-036, A50584-037, A50584-038, A50584-039, A50591-011, A50591-012, A50591-013, A50591-015, A50591-016, A50591-017, A50591-018, A50591-019, A50591-020, A50591-021, A50591-022, A50591-023, A50591-024, A50591-025, A50591-026, A50591-028, A50591-032, A50591-033, A50591-034, A50591-035, A50591-036, A50591-044, A50591-053, A50627-011, A50627-012, A50627-013, A50627-014, A50627-015, A50627-016, A50627-017, A50627-018, A50627-019, A50627-020, A50627-021, A50627-022, A50627-023, A50627-024, A50627-025, A50627-026, A50627-028, A50627-029, A50627-030, A50627-031, A50627-033, A50627-035, A50627-036, A50627-037, A50627-038, A50627-039, A50627-040, A50627-042, A50627-043, A50627-044, A50627-045, A50627-046, A50627-047, A50627-048, A50627-049, A50627-050, A50627-051, A50627-052, A50627-053, A50627-054, A50627-055, A50784-043, A50784-075, A51290-012, A51290-013, A51290-014, A51290-015, A51290-021, A51290-022, A51290-023, A51290-024, A51290-025, A51290-026, A51290-027, A51290-028, A51290-029, A51290-030, A51290-031, A51290-034, A51290-035, A51290-036, A51290-037, A51290-038, A51290-039, A51290-040, A51290-041, A51290-042, A51290-043, A51290-044, A51290-045, A51290-046, A51290-047, A51290-048, A51290-049, A51290-050, A51290-051, A51290-052, A51290-053, A51290-054, A51290-055, A51290-056, A51290-057, A51290-058, A51290-059, A51290-060, A51290-061, A51290-062, A51290-063; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212, GTIN 00763000244736, Serial Numbers: A45398-050, A45398-051, A45398-052, A45398-053, A45398-054, A45398-055, A45398-056, A45398-057, A45398-058, A45398-059, A45398-060, A45398-061, A45398-062, A45398-063, A45930-031, A45930-032, A45930-033, A45930-034, A45930-035, A45930-036, A45930-037, A45930-038, A45930-039, A45930-040, A45930-041, A45930-042, A45930-043, A45930-044, A45930-045, A45930-046, A45930-047, A45930-048, A45930-049, A45930-050, A45930-051, A45930-052, A47605-013, A47605-015, A47605-016, A47605-017, A47605-020, A47605-021, A47605-023, A47605-024, A47605-031, A47605-032, A47605-037, A47605-038, A47687-012, A47687-013, A47687-014, A47687-015, A47687-016, A47687-017, A47687-018, A47687-019, A47687-020, A47687-024, A47687-025, A47687-026, A47687-027, A47687-028, A47687-029, A47687-030, A47687-031, A47687-032, A47687-033, A47687-034, A47687-035, A47687-036, A47687-037, A47687-038, A47687-039, A47687-040, A48349-012, A48349-013, A48349-014, A48349-015, A48349-016, A48349-017, A48349-019, A48349-020, A48349-021, A48349-022, A48349-023, A48349-024, A48349 -025, A48349-026, A48349-027, A48349-028, A48349-029, A48349-030, A48349-031, A48349-032, A48349-033, A48349-034, A48349-035, A48744-011, A48744-012, A48744-013, A48744-014, A48744-015, A48744-016, A48744-017, A48744-018, A48744-019, A48744-020, A48744-021, A48744-022, A48744-023, A48744-024, A48744-033, A48744-034, A48744-035, A48744-036, A48744-040, A48744-041, A48744-042, A48744-044, A48744-045, A48744-046, A48744-047, A48744-048, A48744-049, A48744-050, A48744-051, A48744-052, A48744-053, A48744-054, A48744-055, A48744-056, A48744-057, A48744-058, A48744-059, A48744-060, A48744-061, A48744-062, A49017-011, A49017-012, A49017-013, A49017-014, A49017-016, A49017-017, A49017-018, A49017-021, A49017-024, A49017-025, A49017-026, A49017-027, A49017-028, A49017-029, A49017-030, A49017-031, A49017-032, A49017-033, A49017-034, A49017-035, A49017-036, A49092-011, A49092-012, A49092-013, A49092-014, A49092-015, A49092-018, A49092-019, A49092-020, A49092-021, A49092-022, A49092-023, A49092-026, A49092-028, A49092-029, A49092-030, A49092-031, A49092-033, A49092-035, A49092-036, A49092-038, A49092-039, A49111-013, A49111-014, A49111-029, A49111-031, A49111-032, A49111-033, A49111-034, A49111-036, A49202-011, A49202-012, A49202-013, A49202-014, A49202-015, A49202-016, A49202-017, A49202-018, A49202-019, A49202-020, A49202-021, A49202-022, A49202-023, A49202-024, A49202-025, A49202-026, A49202-027, A49202-028, A49202-029, A49202-030, A49202-031, A49202-032, A49202-033, A49202-034, A49202-035, A49202-036, A49202-037, A49505-011, A49505-012, A49505-013, A49505-014, A49505-015, A49505-016, A49505-017, A49505-018, A49505-019, A49505-020, A49505-021, A49505-022, A49505-023, A49505-026, A49505-027, A49505-028, A49505-029, A49505-030, A49505-031, A49608-011, A49608-012, A49608-013, A49608-014, A49608-015, A49608-016, A49608-017, A49608-018, A49608-019, A49608-020, A49608-021, A49608-022, A49608-023, A49608-024, A49608-025, A49608-026, A49608-027, A49608-028, A49608-029, A49608-030, A49608-031, A49608-032, A49608-033, A49608-034, A49608-035, A49608-036, A49608-037, A49608-038, A49608-040, A49608-041, A49608-042, A49608-043, A49608-044, A49608-045, A49608-046, A49608-047, A49608-048, A49608-049, A49608-050, A49608-051, A49608-052, A49608-053, A49608-054, A49608-055, A49608-056, A49608-057, A49608-058, A49608-059, A49671-011, A49671-012, A49671-013, A49671-015, A49671-016, A49671-017, A49671-018, A49671-019, A49671-020, A49671-021, A49671-022, A49671-023, A49671-024, A49671-025, A49671-026, A49671-027, A49671-028, A49671-029, A49671-030, A49671-031, A49671-032, A49671-033, A49671-034, A49671-035, A49671-036, A49671-037, A49671-038, A49671-039, A49671-040, A49671-041, A49671-042, A49671-043, A49671-044, A49671-045, A49671-046, A49671-047, A49671-048, A49671-049, A49671-050, A49688-011, A49688-012, A49688-013, A49688-014, A49688-015, A49688-016, A49688-017, A49688-018, A49688-019, A49688-020, A49688-021, A49688-022, A49688-023, A49688-024, A49688-025, A49688-026, A49688-027, A49688-028, A49688-029, A49688-030, A49688-031, A49688-032, A49688-033, A49688-034, A49688-035, A49688-036, A49688-037, A49688-038, A49688-039, A49688-040, A49688-041, A49688-042, A49688-043, A49688-044, A49688-045, A49688-046, A49688-047, A49688-050, A49688-051, A49688-052, A49688-053, A49688-054, A49688-056, A49688-058, A49688-059, A49688-060, A49688-061, A49688-062, A49721-011, A49721-012, A49721-013, A49721-014, A49721-015, A49721-016, A49721-017, A49721-018, A49721-019, A49721-020, A49721-021, A49721-022, A49721-023, A49721-024, A49721-025, A49721-026, A49721-027, A49721-028, A49721-029, A49721-031, A49721-032, A49721-033, A49721-034, A49721-035, A49721-036, A49721-037, A49721-038, A49721-039, A49721-042, A49721-043, A49721-044, A49721-045, A49721-046, A49721-047, A49721-048, A49721-049, A49721-050, A49721-051, A49721-052, A49721-053, A49721-054, A49721-055, A50310-023, A50310-025, A50310-026, A50310-027, A50310-028, A50310-029, A50310-030, A50310-031, A50310-032, A50310-033, A50310-034, A50310-035, A50310-036, A50310-037, A50310-049, A50310-050, A50310-051, A50310-052, A50584-065, A50584-066, A50584-068, A50584-070, A50584-071, A50584-072, A50584-073, A50584-074, A50584-075, A50584-076, A52171-047.

Quantity recalled3037 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1332-2023
FDA event ID: 91697
Recalling firm: Medtronic Sofamor Danek USA, Memphis, TN
Classification: Class II
Status: Ongoing
Recall initiated: 8 Feb 2023
FDA classified: 4 Apr 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

8 Feb 2023	Recall initiated by company
4 Apr 2023	Classified by FDA	+55 days
12 Apr 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Which lots are affected?

a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012, A45206-013, A45206-014, A45206-016, A45206-018, A45206-019, A45206-020, A45206-021, A45206-022, A45206-023, A45206-024, A45206-025, A45206-026, A45206-027, A45206-028, A45206-029, A45206-030, A45206-031, A45206-032, A45206-033, A45206-034, A45206-035, A45206-036, A45206-037, A45206-038, A45206-040, A45206-041, A45206-042, A45206-043, A45206-045, A45206-046, A45206-047, A45206-048, A45206-049, A45206-050, A45206-051, A45206-052, A45206-053, A45206-054, A45206-055, A45206-056, A45206-057, A45206-058, A45206-061, A45206-063, A45206-064, A45206-066, A45206-067, A45206-068, A45206-069, A45206-070, A45206-071, A45206-072, A45489-011, A45489-012, A45489-015, A45489-016, A45489-017, A45489-021, A45489-022, A45489-023, A45489-024, A45489-025, A45489-026, A45489-027, A45489-028, A45489-030, A45489-032, A45489-036, A45489-037, A45489-038, A45489-039, A45489-040, A45489-041, A45489-042, A45489-045, A45489-046, A45489-047, A45489-048, A45489-049, A45489-050, A45489-051, A45870-011, A45870-012, A45870-013, A45870-014, A45870-015, A45870-016, A45870-017, A45870-018, A45870-019, A45870-020, A45870-021, A45870-022, A45870-023, A45870-025, A45870-026, A45870-027, A45870-032, A45870-033, A45870-036, A45870-038, A45870-039, A45870-040, A45870-041, A45870-042, A45870-043, A45870-044, A45870-045, A45870-046, A45870-047, A46716-036, A46716-037, A46716-038, A46716-039, A46716-040, A46716-041, A46716-042, A46716-044, A46716-046, A46716-047, A46716-048, A46716-051, A46716-054, A46716-055, A46716-056, A46716-057, A46716-058, A46716-060, A46716-061, A46716-062, A46716-065, A46716-066, A46716-067, A46716-069, A46716-070, A46716-071, A46716-072, A46716-073, A46716-074, A46716-075, A46716-076, A46716-080, A46716-081, A46716-082, A46716-083, A46716-084, A46716-085, A46716-086, A46716-087, A46716-088, A46716-089, A46716-090, A46716-091, A46716-092, A46716-093, A46716-094, A46716-095, A46716-096, A46716-107, A48729-045, A49241-011, A49241-012, A49241-013, A49241-014, A49241-016, A49241-017, A49241-018, A49241-019, A49241-020, A49241-021, A49241-022, A49241-023, A49241-024, A49241-025, A49241-026, A49241-027, A49241-028, A49241-029, A49241-030, A49241-031, A49241-032, A49241-033, A49241-034, A49241-035, A49241-036, A49241-037, A49241-038, A49241-039, A49241-040, A49241-041, A49241-042, A49241-043, A49241-044, A49241-045, A49241-046, A49241-047, A49241-048, A49241-049, A49241-050, A49241-051, A49241-052, A49241-053, A49241-054, A49241-055, A49241-056, A49241-057, A49241-058, A49241-059, A49241-060, A49241-061, A49241-062, A49241-063, A49241-064, A49241-065, A49241-067, A49241-068, A49241-069, A49241-070, A49241-071, A49241-072, A49241-073, A49241-074, A49241-076, A49241-078, A49241-079, A49241-080, A49241-081, A49241-082, A49241-083, A49241-084, A49241-086, A49241-088, A49241-089, A49241-090, A49241-091, A49241-093, A49241-095, A49241-096, A49241-098, A49241-099, A49241-100, A49241-101, A49241-102, A49241-103, A49241-104, A49241-105, A49555-011, A49555-012, A49555-013, A49555-014, A49555-022, A49555-024, A49555-026, A49555-027, A49555-028, A49555-029, A49555-030, A49555-031, A49555-032, A49555-035, A49818-011, A49818-012, A49818-013, A49818-014, A49818-015, A49818-016, A49818-017, A49818-018, A49818-020, A49818-022, A49818-023, A49818-025, A49818-026, A49818-027, A49818-028, A49818-029, A49818-030, A49818-031, A49818-032, A49818-034, A49818-035, A49818-036, A49818-037, A49818-038, A49818-039, A49818-040, A49818-041, A49818-042, A49818-043, A49818-044, A49818-045, A49818-048, A49818-049, A49818-050, A49818-051, A49818-052, A49818-053, A49818-054, A49818-055, A49818-056, A49818-057, A49818-058, A49818-059, A49818-060, A49818-061, A49818-062, A49818-063, A49818-064, A49818-065, A49818-066, A49818-067, A49818-068, A49818-069, A49818-071, A49818-072, A49818-073, A49818-074, A49818-075, A49818-076, A49818-077, A49818-079, A49818-080, A49818-081, A49818-082, A49818-083, A49818-084, A49818-085, A49818-086, A49818-087, A49818-088, A49818-089, A49818-090, A49818-091, A49818-092, A49818-093, A49818-094, A49818-095, A49818-096, A49818-097, A49818-098, A49818-099, A49818-100, A49818-101, A50197-011, A50197-014, A50197-015, A50197-017, A50197-018, A50197-019, A50197-020, A50197-021, A50197-022, A50197-024, A50197-025, A50197-026, A50197-027, A50197-028, A50197-029, A50197-030, A50197-031, A50197-032, A50197-033, A50197-034, A50197-035, A50197-036, A50197-037, A50197-038, A50197-039, A50197-040, A50197-041, A50197-042, A50197-043, A50197-047, A50197-048, A50197-049, A50197-050, A50197-051, A50197-052, A50197-053, A50197-054, A50197-055, A50197-056, A50197-057, A50197-058, A50197-059, A50197-060, A50197-061, A50197-062, A50197-063, A50197-064, A50197-065, A50197-066, A50197-067, A50197-068, A50197-069, A50197-070, A50197-071, A50197-072, A50197-073, A50197-074, A50197-075, A50197-076, A50197-077, A50197-078, A50197-079; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206, GTIN 00763000244712, Serial Numbers: A42287-087, A42287-088, A42287-089, A42287-090, A42287-092, A42287-093, A42287-094, A42287-095, A42287-100, A42287-101, A42287-102, A42287-103, A42287-104, A42287-105, A42287-108, A42287-112, A42287-113, A42287-114, A42287-116, A42287-117, A42287-118, A42287-119, A42287-121, A42287-122, A42287-123, A42287-124, A42287-125, A42287-126, A42287-160, A42287-161, A42287-162, A42287-163, A42287-164, A42287-165, A42287-166, A42287-167, A45179-026, A45179-027, A45179-028, A45179-029, A45179-030, A45179-031, A45179-032, A45179-033, A45179-034, A45179-036, A45179-037, A45179-038, A45179-039, A45179-040, A45179-041, A45179-042, A45179-043, A45179-044, A45179-045, A45179-046, A45179-047, A45179-048, A45179-051, A45179-052, A45179-054, A45179-055, A45179-056, A45179-057, A45179-058, A45179-059, A45179-060, A45179-061, A45179-062, A45179-063, A45179-064, A45492-013, A45492-014, A45492-015, A45492-016, 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A47321-029, A47321-030, A47321-031, A47321-032, A47321-033, A47321-034, A47321-035, A47321-036, A47321-037, A47321-038, A47321-039, A47321-040, A47321-041, A47321-042, A47321-043, A47321-044, A48003-011, A48003-012, A48003-013, A48003-014, A48003-015, A48003-016, A48003-017, A48003-018, A48003-019, A48003-020, A48003-021, A48003-022, A48003-023, A48003-024, A48003-025, A48003-026, A48003-027, A48003-028, A48003-029, A48003-030, A48003-031, A48003-032, A48003-033, A48003-034, A48003-035, A48003-036, A48003-037, A48003-039, A48003-040, A48003-041, A48003-042, A48003-043, A48003-044, A48003-045, A48003-046, A48003-047, A48003-048, A48003-049, A48003-050, A48003-051, A48003-052, A48003-053, A48003-054, A48003-055, A48003-056, A48003-057, A48003-058, A48003-059, A48003-060, A48003-061, A48003-062, A48003-063, A48003-064, A48003-065, A48003-066, A48003-067, A48003-068, A48003-069, A48003-070, A48003-071, A48003-072, A48003-073, A48003-074, A48003-075, A48003-076, A48003-077, A48003-078, 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A49125-098, A49125-099, A49125-100, A49125-101, A49125-102, A49125-103, A49125-104, A49125-105, A49125-106, A49125-107, A49125-110, A49125-111, A49125-112, A49125-113, A49125-114, A49125-115, A49125-116, A49125-117, A49176-011, A49176-012, A49176-013, A49176-014, A49176-015, A49176-016, A49176-017, A49176-018, A49176-019, A49176-020, A49176-021, A49176-022, A49176-023, A49176-028, A49176-030, A49176-031, A49176-032, A49176-033, A49176-034, A49176-035, A49176-036, A49176-037, A49176-038, A49176-039, A49176-040, A49176-041, A49176-042, A49176-043, A49176-044, A49176-045, A49176-046, A49176-047, A49176-048, A49176-049, A49176-050, A49176-051, A49176-052, A49176-053, A49176-054, A49176-055, A49176-056, A49176-057, A49176-058, A49240-011, A49240-012, A49240-013, A49240-014, A49240-015, A49240-016, A49240-017, A49240-018, A49240-019, A49240-020, A49240-021, A49240-022, A49240-023, A49240-024, A49240-025, A49240-026, A49240-027, A49240-028, A49240-029, A49240-030, A49240-031, A49240-032, 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A49488-038, A49488-039, A49488-040, A49488-042, A49488-043, A49488-044, A49488-045, A49488-046, A49488-047, A49488-048, A49488-049, A49488-050, A49488-051, A49488-052, A49488-053, A49488-054, A49488-055, A49488-056, A49488-057, A49488-058, A49488-059, A49488-060, A49488-061, A49488-062, A49488-063, A49488-064, A49488-065, A49488-066, A49488-069, A49488-070, A49488-071, A49488-072, A49488-073, A49488-074, A49488-075, A49488-076, A49488-077, A49492-011, A49492-012, A49492-013, A49492-014, A49492-015, A49492-016, A49492-017, A49492-018, A49492-019, A49492-020, A49492-021, A49492-022, A49492-023, A49492-024, A49492-025, A49492-026, A49492-028, A49492-029, A49492-030, A49492-031, A49492-032, A49492-033, A49492-034, A49492-035, A49492-036, A49492-037, A49492-038, A49492-039, A49492-040, A49492-041, A49492-042, A49492-043, A49492-044, A49492-045, A49492-046, A49492-047, A49492-048, A49492-049, A49492-050, A49492-051, A49492-052, A49492-054, A49492-055, A49492-056, A49492-057, A49492-058, A49492-059, A49492-060, A49492-061, A49492-062, A49492-063, A49492-064, A49492-065, A49492-066, A49492-067, A49492-068, A49492-069, A49492-070, A49492-071, A49492-072, A49492-073, A49492-074, A49492-075, A49492-076, A49492-077, A49492-078, A49492-079, A49492-080, A49549-012, A49549-013, A49549-014, A49549-015, A49549-016, A49549-030, A49549-037, A49549-039, A49549-040, A49549-041, A49549-042, A49549-043, A49549-044, A49549-045, A49549-046, A49549-047, A49549-048, A49549-092, A49549-102, A49665-011, A49665-012, A49665-013, A49665-014, A49665-015, A49665-016, A49665-017, A49665-018, A49665-019, A49665-020, A49665-021, A49665-022, A49665-023, A49665-024, A49665-025, A49665-026, A49665-028, A49665-029, A49665-034, A49665-035, A49665-036, A49665-037, A49665-038, A49665-039, A49665-040, A49665-043, A49665-044, A49665-045, A49665-046, A49665-047, A49665-048, A49665-049, A49665-050, A49665-051, A49665-052, A49665-053, A49665-056, A49665-058, A49665-059, A49665-061, A49665-062, A49665-063, A49665-064, A49665-065, A49665-066, A49665-067, A49665-068, A49665-069, A49665-070, A49665-071, A49665-072, A49665-073, A49665-074, A49665-075, A49665-076, A49665-077, A49665-078, A49665-079, A49665-080, A49665-081, A49665-082, A49665-083, A49665-084, A49665-085, A49822-012, A49822-013, A49822-014, A49822-015, A49822-016, A49822-017, A49822-018, A49822-019, A49822-021, A49822-022, A49822-023, A49822-024, A49822-027, A49822-028, A49822-029, A49822-030, A49822-031, A49822-032, A49822-033, A49822-034, A49822-035, A49822-036, A49822-037, A49822-038, A49822-039, A49822-040, A49822-041, A49822-042, A49822-043, A49822-044, A49822-045, A49822-046, A49822-047, A49822-048, A49822-049, A49822-050, A49822-052, A49822-054, A49822-055, A49822-056, A49822-057, A49822-058, A49822-059, A49822-061, A49822-062, A49822-063, A49822-064, A49822-065, A49822-066, A49822-067, A49822-068, A49822-069, A49822-070, A49822-071, A49822-072, A49822-073, A49822-074, A49822-075, A49822-076, A49822-077, A49822-078, A49822-079, A49822-080, A50132-011, A50132-012, A50132-013, A50132-014, A50132-015, A50132-016, A50132-017, A50132-018, A50132-019, A50132-020, A50132-021, A50132-022, A50132-023, A50132-024, A50132-025, A50132-026, A50132-027, A50132-028, A50132-029, A50132-030, A50132-031, A50132-032, A50132-033, A50132-034, A50132-035, A50132-036, A50132-037, A50132-038, A50132-039, A50132-040, A50132-041, A50132-042, A50132-043, A50132-044, A50132-045, A50132-046, A50132-047, A50132-048, A50132-049, A50132-050, A50132-051, A50132-052, A50132-053, A50132-054, A50132-055, A50132-056, A50132-057, A50132-058, A50132-059, A50132-060, A50132-061, A50132-062, A50132-063, A50132-064, A50132-065, A50132-066, A50132-067, A50132-068, A50132-069, A50132-070, A50132-071, A50132-072, A50132-073, A50132-074, A50132-075, A50132-076, A50132-077, A50132-078, A50132-079, A50132-080, A50132-081, A50132-082, A50132-083, A50132-084, A50132-085, A50132-086, A50132-087, A50132-088, A50132-089, A50132-090, A50132-091, A50132-092, A50132-093, A50132-094, A50132-095, A50132-096, A50132-097, A50132-098, A50132-099, A50132-100, A50132-101, A50224-011, A50224-012, A50224-013, A50224-014, A50224-015, A50224-016, A50224-019, A50224-020, A50224-021, A50224-022, A50224-023, A50224-024, A50224-025, A50224-026, A50224-027, A50224-028, A50224-029, A50224-030, A50224-031, A50224-032, A50224-033, A50224-034, A50224-035, A50224-036, A50224-037, A50224-038, A50224-039, A50224-040, A50224-042, A50224-043, A50224-044, A50224-045, A50224-046, A50224-047, A50224-048, A50224-049, A50224-053, A50224-054, A50224-055, A50224-056, A50224-057, A50224-058, A50224-059, A50224-060, A50224-061, A50224-062, A50224-063, A50224-064, A50224-065, A50224-066, A50224-067, A50224-068, A50224-069, A50224-070, A50299-011, A50299-012, A50299-013, A50299-014, A50299-015, A50299-016, A50299-017, A50299-018, A50299-019, A50299-020, A50299-023, A50299-024, A50299-025, A50299-026, A50299-027, A50299-028, A50299-029, A50299-030, A50299-031, A50299-033, A50299-034, A50299-037, A50299-038, A50299-039, A50299-040, A50299-041, A50299-042, A50299-043, A50299-044, A50299-045, A50299-046, A50299-047, A50299-048, A50299-049, A50299-050, A50299-051, A50299-052, A50299-053, A50299-054, A50299-055, A50299-056, A50299-057, A50299-058, A50299-059, A50299-060, A50299-061, A50299-065, A50299-067, A50299-068, A50299-069, A50299-070, A50299-071, A50299-072, A50299-073, A50299-074, A50299-075, A50299-076, A50299-077, A50299-078, A50299-079, A50299-080, A50299-081, A50299-082, A50299-083, A50299-084, A50299-085, A50299-086, A50299-087, A50299-088, A50299-089, A50299-090, A50299-091, A50299-092, A50299-093, A50299-094, A50299-095, A50299-096, A50299-097, A50299-098, A50299-099, A50299-100, A50299-101, A50784-029, A50784-030; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209, GTIN 00763000244729, Serial Numbers: A45398-036, A45398-037, A45398-038, A45398-039, A45398-040, A45398-041, A45398-042, A45398-043, A45398-044, A45398-045, A45398-046, A45398-047, A45398-048, A45398-049, A46088-011, A46088-012, A46088-013, A46088-014, A46088-015, A46088-016, A46088-017, A46088-018, A46088-019, A46088-020, A46088-021, A46088-022, A46088-023, A46088-024, A46088-025, A46088-026, A46088-027, A46088-029, A46088-030, A46088-031, A46088-032, A46088-033, A46088-034, A46088-035, A46088-036, A46088-037, A46088-038, A46088-039, A46088-040, A46088-042, A46088-043, A46088-044, A46088-045, A46948-011, A46948-012, A46948-015, A46948-017, A46948-018, A46948-019, A46948-020, A46948-021, A46948-022, A46948-023, A46948-026, A46948-027, A46948-028, A46948-029, A46948-030, A46948-031, A46948-032, A46948-033, A46948-034, A46948-039, A46948-040, A46948-041, A46948-042, A46948-043, A46948-044, A46948-046, A46948-047, A46948-048, A46948-049, A46948-051, A46948-053, A46948-054, A48537-048, A48537-049, A48537-050, A48537-051, A48537-052, A48537-053, A48537-054, A48537-055, A48537-056, A48537-057, A48537-058, A48537-059, A48537-060, A48537-061, A48537-062, A48537-063, A48537-064, A48537-065, A48537-066, A48537-067, A48537-068, A48537-069, A48537-072, A48537-073, A48537-074, A48537-075, A48537-076, A48537-077, A48537-078, A48537-079, A48537-082, A49119-011, A49119-012, A49119-013, A49119-014, A49119-015, A49119-016, A49119-017, A49119-018, A49119-019, A49119-020, A49119-021, A49119-022, A49119-023, A49119-024, A49119-025, A49119-026, A49119-027, A49119-028, A49119-029, A49119-030, A49119-031, A49119-032, A49119-033, A49119-035, A49119-036, A49119-038, A49119-039, A49119-040, A49119-042, A49119-043, A49119-044, A49119-045, A49119-046, A49119-047, A49119-048, A49119-049, A49119-050, A49409-011, A49409-012, A49409-013, A49409-014, A49409-015, A49409-016, A49409-017, A49409-018, A49409-019, A49409-020, A49409-021, A49409-022, A49409-023, A49409-024, A49409-025, A49409-026, A49409-027, A49409-028, A49409-029, A49409-030, A49409-031, A49409-033, A49409-034, A49409-035, A49409-036, A49409-037, A49409-038, A49409-039, A49409-041, A49409-042, A49409-043, A49409-044, A49409-045, A49409-046, A49409-047, A49409-048, A49409-049, A49409-050, A49409-051, A49409-052, A49409-053, A49409-054, A49409-055, A49409-056, A49409-057, A49409-058, A49409-059, A49554-011, A49554-012, A49554-013, A49554-014, A49554-015, A49554-020, A49554-021, A49554-022, A49554-023, A49554-024, A49554-025, A49554-026, A49554-027, A49554-028, A49554-029, A49554-030, A49554-031, A49554-032, A49554-033, A49554-034, A49554-036, A49554-037, A49554-038, A49554-039, A49554-040, A49554-041, A49554-042, A49554-043, A49554-044, A49554-045, A49554-046, A49554-047, A49554-048, A49554-050, A49554-051, A49554-052, A49554-053, A49554-054, A49554-055, A49554-056, A49554-057, A49554-058, A49554-059, A49554-060, A49554-063, A49554-065, A49554-066, A49606-011, A49606-012, A49606-013, A49606-014, A49606-015, A49606-016, A49606-017, A49606-020, A49606-021, A49606-022, A49606-023, A49606-024, A49606-025, A49606-026, A49606-027, A49606-028, A49606-029, A49606-030, A49606-032, A49606-033, A49606-034, A49606-035, A49606-036, A49606-037, A49606-038, A49606-039, A49606-040, A49606-041, A49606-042, A49606-043, A49606-044, A49606-045, A49606-046, A49606-047, A49606-048, A49606-049, A49606-050, A49606-051, A49606-052, A49606-053, A49606-055, A49606-056, A49606-058, A49606-059, A49606-060, A49606-061, A49606-065, A49606-066, A49606-067, A49606-069, A49606-070, A49652-012, A49652-018, A49652-019, A49652-021, A49652-022, A49652-023, A49652-024, A49652-025, A49652-026, A49652-027, A49652-028, A49652-029, A49652-032, A49652-033, A49652-034, A49652-035, A49652-036, A49652-037, A49652-038, A49652-039, A49652-040, A49652-041, A49652-042, A49652-043, A49652-044, A49652-045, A49652-046, A49652-047, A49652-048, A49652-049, A49652-051, A49652-052, A49652-053, A49652-055, A49652-056, A49652-057, A49652-058, A49652-059, A49652-060, A49652-061, A49652-062, A49652-063, A49652-064, A49652-065, A49652-066, A49707-036, A49707-037, A49707-038, A49707-039, A49707-041, A49707-042, A49707-045, A49707-046, A49707-047, A49707-048, A49707-049, A49707-050, A49707-051, A49707-052, A49707-053, A49707-054, A49707-055, A49707-056, A49707-057, A49707-058, A49707-059, A49707-060, A49707-061, A49707-062, A49707-063, A49810-011, A49810-012, A49810-013, A49810-014, A49810-015, A49810-016, A49810-017, A49810-018, A49810-019, A49810-021, A49810-023, A49810-026, A49810-027, A49810-028, A49810-029, A49810-030, A49810-031, A49810-032, A49810-033, A49810-034, A49810-036, A49810-038, A49810-040, A49810-041, A50025-012, A50025-013, A50025-014, A50025-015, A50025-016, A50025-017, A50025-018, A50025-019, A50025-020, A50025-021, A50025-022, A50025-023, A50025-024, A50025-025, A50025-026, A50025-027, A50025-029, A50025-030, A50025-031, A50025-032, A50025-033, A50025-034, A50025-035, A50025-036, A50025-037, A50025-038, A50025-039, A50025-040, A50025-041, A50025-042, A50025-043, A50025-044, A50025-045, A50025-046, A50025-047, A50025-048, A50025-049, A50025-050, A50025-051, A50025-052, A50025-053, A50025-054, A50025-055, A50025-056, A50025-057, A50025-058, A50025-059, A50025-060, A50025-061, A50473-011, A50473-012, A50473-013, A50473-014, A50473-015, A50473-016, A50473-017, A50473-018, A50473-019, A50473-020, A50473-021, A50473-022, A50473-023, A50473-024, A50473-025, A50473-026, A50473-027, A50473-028, A50473-029, A50473-030, A50473-031, A50473-032, A50473-033, A50473-034, A50473-035, A50473-036, A50473-037, A50473-038, A50473-039, A50473-040, A50473-041, A50473-042, A50473-043, A50473-044, A50473-045, A50473-046, A50473-047, A50574-011, A50574-012, A50574-013, A50574-014, A50574-015, A50574-028, A50574-029, A50574-030, A50574-031, A50574-032, A50574-033, A50574-034, A50574-035, A50574-036, A50574-037, A50574-038, A50574-039, A50574-041, A50574-042, A50574-043, A50574-044, A50574-045, A50574-046, A50574-047, A50574-048, A50574-049, A50574-050, A50574-051, A50574-052, A50574-053, A50574-054, A50574-055, A50574-056, A50574-057, A50574-058, A50574-059, A50584-011, A50584-012, A50584-013, A50584-014, A50584-015, A50584-017, A50584-018, A50584-019, A50584-020, A50584-021, A50584-022, A50584-023, A50584-024, A50584-025, A50584-026, A50584-027, A50584-028, A50584-036, A50584-037, A50584-038, A50584-039, A50591-011, A50591-012, A50591-013, A50591-015, A50591-016, A50591-017, A50591-018, A50591-019, A50591-020, A50591-021, A50591-022, A50591-023, A50591-024, A50591-025, A50591-026, A50591-028, A50591-032, A50591-033, A50591-034, A50591-035, A50591-036, A50591-044, A50591-053, A50627-011, A50627-012, A50627-013, A50627-014, A50627-015, A50627-016, A50627-017, A50627-018, A50627-019, A50627-020, A50627-021, A50627-022, A50627-023, A50627-024, A50627-025, A50627-026, A50627-028, A50627-029, A50627-030, A50627-031, A50627-033, A50627-035, A50627-036, A50627-037, A50627-038, A50627-039, A50627-040, A50627-042, A50627-043, A50627-044, A50627-045, A50627-046, A50627-047, A50627-048, A50627-049, A50627-050, A50627-051, A50627-052, A50627-053, A50627-054, A50627-055, A50784-043, A50784-075, A51290-012, A51290-013, A51290-014, A51290-015, A51290-021, A51290-022, A51290-023, A51290-024, A51290-025, A51290-026, A51290-027, A51290-028, A51290-029, A51290-030, A51290-031, A51290-034, A51290-035, A51290-036, A51290-037, A51290-038, A51290-039, A51290-040, A51290-041, A51290-042, A51290-043, A51290-044, A51290-045, A51290-046, A51290-047, A51290-048, A51290-049, A51290-050, A51290-051, A51290-052, A51290-053, A51290-054, A51290-055, A51290-056, A51290-057, A51290-058, A51290-059, A51290-060, A51290-061, A51290-062, A51290-063; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212, GTIN 00763000244736, Serial Numbers: A45398-050, A45398-051, A45398-052, A45398-053, A45398-054, A45398-055, A45398-056, A45398-057, A45398-058, A45398-059, A45398-060, A45398-061, A45398-062, A45398-063, A45930-031, A45930-032, A45930-033, A45930-034, A45930-035, A45930-036, A45930-037, A45930-038, A45930-039, A45930-040, A45930-041, A45930-042, A45930-043, A45930-044, A45930-045, A45930-046, A45930-047, A45930-048, A45930-049, A45930-050, A45930-051, A45930-052, A47605-013, A47605-015, A47605-016, A47605-017, A47605-020, A47605-021, A47605-023, A47605-024, A47605-031, A47605-032, A47605-037, A47605-038, A47687-012, A47687-013, A47687-014, A47687-015, A47687-016, A47687-017, A47687-018, A47687-019, A47687-020, A47687-024, A47687-025, A47687-026, A47687-027, A47687-028, A47687-029, A47687-030, A47687-031, A47687-032, A47687-033, A47687-034, A47687-035, A47687-036, A47687-037, A47687-038, A47687-039, A47687-040, A48349-012, A48349-013, A48349-014, A48349-015, A48349-016, A48349-017, A48349-019, A48349-020, A48349-021, A48349-022, A48349-023, A48349-024, A48349 -025, A48349-026, A48349-027, A48349-028, A48349-029, A48349-030, A48349-031, A48349-032, A48349-033, A48349-034, A48349-035, A48744-011, A48744-012, A48744-013, A48744-014, A48744-015, A48744-016, A48744-017, A48744-018, A48744-019, A48744-020, A48744-021, A48744-022, A48744-023, A48744-024, A48744-033, A48744-034, A48744-035, A48744-036, A48744-040, A48744-041, A48744-042, A48744-044, A48744-045, A48744-046, A48744-047, A48744-048, A48744-049, A48744-050, A48744-051, A48744-052, A48744-053, A48744-054, A48744-055, A48744-056, A48744-057, A48744-058, A48744-059, A48744-060, A48744-061, A48744-062, A49017-011, A49017-012, A49017-013, A49017-014, A49017-016, A49017-017, A49017-018, A49017-021, A49017-024, A49017-025, A49017-026, A49017-027, A49017-028, A49017-029, A49017-030, A49017-031, A49017-032, A49017-033, A49017-034, A49017-035, A49017-036, A49092-011, A49092-012, A49092-013, A49092-014, A49092-015, A49092-018, A49092-019, A49092-020, A49092-021, A49092-022, A49092-023, A49092-026, A49092-028, A49092-029, A49092-030, A49092-031, A49092-033, A49092-035, A49092-036, A49092-038, A49092-039, A49111-013, A49111-014, A49111-029, A49111-031, A49111-032, A49111-033, A49111-034, A49111-036, A49202-011, A49202-012, A49202-013, A49202-014, A49202-015, 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Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 91697

This product is part of a recall event; the main page for the event is Medtronic Grafton Crunch a) Dbm S44105 Grafton 5CC Crunch recalled.

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023	CLASS II	Medtronic Grafton Crunch a) Dbm S44105 Grafton 5CC Crunch recalled	Medtronic Sofamor Danek USA	Sterility	Nationwide
12 Apr 2023	CLASS II	Medtronic Xpanse Bone Insert: a) Dbm T600106 Xpanse Small-c recalled	Medtronic Sofamor Danek USA	Sterility	Nationwide
12 Apr 2023	CLASS II	Medtronic Grafton Flex: a) Dbm S42090 Grafton X Flex recalled	Medtronic Sofamor Danek USA	Sterility	Nationwide

More recalls from Medtronic Sofamor Danek USA

All 79

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Grafton" DBM and Grafton Plus" DBM contain demineralized recalled	Medtronic Sofamor Danek USA	Other Bacterial Contamination	Nationwide
21 Oct 2026Device	CLASS II	Grafton" DBM and Grafton Plus" DBM contain demineralized recalled	Medtronic Sofamor Danek USA	Other Bacterial Contamination	Nationwide
3 Dec 2025Device	CLASS II	Catalyft PL & PL40 Expandable Interbody System labeled as recalled	Medtronic Sofamor Danek USA	Other	Nationwide
1 Nov 2023Device	CLASS II	Grafton DBM Crunch recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Matrix Strips recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN

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All 13,968

Reported	Class	Recall	Company	Reason	Where
4 Nov 2026Device	CLASS II	Philips Azurion 3 M15 recalled by Philips Medical Systems Nederl	Philips Medical Systems Nederl	Other	Nationwide
4 Nov 2026Device	CLASS II	Orthoscan Versa Accessory Cart recalled by Ziehm-orthoscan	Ziehm-orthoscan	Device Malfunction	Nationwide
4 Nov 2026Device	CLASS II	Philips Azurion 7 B12 recalled by Philips Medical Systems Nederl	Philips Medical Systems Nederl	Other	Nationwide
4 Nov 2026Device	CLASS II	Philips Azurion 7 M20 recalled by Philips Medical Systems Nederl	Philips Medical Systems Nederl	Other	Nationwide
4 Nov 2026Device	CLASS II	Carevo, Height-adjustable shower trolley recalled	Arjohuntleigh Polska Sp. z.o.o	Other	Nationwide