CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report
Grafton DBM Crunch recalled by Medtronic Sofamor Danek USA
Medtronic Sofamor Danek USA is recalling Grafton DBM Crunch. The recall was initiated on 26 Sep 2023 and the FDA has classified it as Class II.
Check your package
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-0161-2024
- FDA event ID
- 93163
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Sep 2023
- FDA classified
- 24 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Other Medical Devices
Timeline
| 26 Sep 2023 | Recall initiated by company | |
| 24 Oct 2023 | Classified by FDA | +28 days |
| 1 Nov 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
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Where it was distributed
US, Colombia, S. Korea, New Zealand, India, Taiwan
Questions about this recall
Why was it recalled?
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Which lots are affected?
GTIN 00643169123113, Serial Numbers: A59083-054, A59083-055, A59083-056, A59083-057, A59083-058, A59083-059, A59083-060, A59083-061, A59083-062, A59083-063, A59083-064, A56737-049, A56737-050, A56737-051, A56737-052, A56737-053, A56737-054, A56737-055, A56737-056, A56737-057, A56737-058, A56737-059, A56737-060, A56737-061, A56737-062, A56737-063, A56858-021, A56858-022, A56858-023, A56858-024, A56858-025, A56858-026, A56858-027, A56858-028, A56858-029, A56858-030, A56858-031, A56858-032, A56858-033, A56858-034, A56858-035, A56858-036, A57174-060, A57174-061, A57174-062, A57174-063, A57174-064, A57174-065, A57174-066, A57174-067, A57174-068, A57174-069, A57174-070, A57174-071, A57617-066, A57617-067, A57617-068, A57617-069, A57617-070, A57617-071, A57617-072, A57617-073, A57617-074, A57617-075, A57617-076, A57617-077, A57617-078, A58281-035, A58281-036, A58281-037, A58281-038, A58281-039, A58281-040, A58281-041, A58281-042, A58281-043, A58281-044, A58281-045, A58281-046, A58281-047, A59083-050, A59083-051, A59083-052, A59083-053
Where was it sold?
US, Colombia, S. Korea, New Zealand, India, Taiwan
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
6 other products · FDA event 93163This product is part of a recall event; the main page for the event is Grafton DBM (Flex) recalled by Medtronic Sofamor Danek USA.
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