CLASS II ONGOING Device recall · Reported 14 Apr 2021 · FDA Enforcement Report
Nuvasive Precice Intramedullary Limb Lengthening (Imll) recalled
Nuvasive Specialized Orthopedics is recalling Nuvasive Precice Intramedullary Limb Lengthening (Imll) and (Short) System End Cap for, distributed nationwide in the US. The recall was initiated on 12 Feb 2021 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-1349-2021
- FDA event ID
- 87353
- Recalling firm
- Nuvasive Specialized Orthopedics, Aliso Viejo, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Feb 2021
- FDA classified
- 5 Apr 2021
- Reported
- 14 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 12 Feb 2021 | Recall initiated by company | |
| 5 Apr 2021 | Classified by FDA | +52 days |
| 14 Apr 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿ +20mm; Packaged End Cap 12.5mm,¿ +0mm; Packaged End Cap 12.5mm,¿ +5mm; Packaged End Cap 12.5mm,¿ +10mm; Packaged End Cap 12.5mm,¿ +15mm; Packaged End Cap 12.5mm,¿ +20mm; 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 4.0 mm Locking Screw 20 mm Length; 4.0 mm Locking Screw 25 mm Length; 4.0 mm Locking Screw 30 mm Length; 4.0 mm Locking Screw 35 mm Length; 4.0 mm Locking Screw 40 mm Length; 4.0 mm Locking Screw 45 mm Length; 4.0 mm Locking Screw 50 mm Length; 4.0 mm Locking Screw 55 mm Length; 4.0 mm Locking Screw 60 mm Length; 4.0 mm X 65 mm Locking Screw, Peg; 4.0 mm X 70 mm Locking Screw, Peg; 4.0 mm X 75 mm Locking Screw, Peg; 4.0 mm X 80 mm Locking Screw, Peg; 4.0 mm X 85 mm Locking Screw, Peg; 4.0 mm X 90 mm Locking Screw, Peg; 4.0 mm X 95 mm Locking Screw, Peg; 4.0 mm X 100 mm Locking Screw, Peg; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; Orthopedic intramedullary limb lengthening rod, retrograde femur 10 degree, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 160 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, universal femur, 10.7 mm diameter, 170 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, retrograde femur, 10 degree, 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening rod, antegrade femur (piriformis), 10.7 mm diameter, 230 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 195 mm length; Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 215 mm length; Orthopedic intramedullary limb lengthening
Where it was distributed
Worldwide distribution, including U.S. Nationwide.
Questions about this recall
Why was it recalled?
Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Which lots are affected?
All Lots manufactured between April 2015 to February 2021. PRECICE Intramedullary Limb Lengthening (IMLL) Product Codes: End caps: CPA1-000; CPA2-000; CPA2-005; CPA2-010; CPA2-015; CPA2-020; CPA3-000; CPA3-005; CPA3-010; CPA3-015; CPA3-020; Locking screws: LSB3-020; LSB3-025; LSB3-030; LSB3-035; LSB3-040; LSB3-045; LSB3-050; LSB3-055; LSB3-060; LSB3-065; LSB3-070; LSB3-075; LSB4-020; LSB4-025; LSB4-030; LSB4-035; LSB4-040; LSB4-045; LSB4-050; LSB4-055; LSB4-060; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC4-020; LSC4-025; LSC4-030; LSC4-035; LSC4-040; LSC4-045; LSC4-050; LSC4-055; LSC4-060; LSC4-065; LSC4-070; LSC4-075; LSC4-080; LSC4-085; LSC4-090; LSC4-095; LSC4-100; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100; Limb lengthening intramedullary rods 10.7 mm diameter: P10.7-30H170; P10.7-30J160; P10.7-30K170; P10.7-30U170; P10.7-50A215; P10.7-50A230; P10.7-50B215; P10.7-50B230; P10.7-50C195; P10.7-50C215; P10.7-50C230; P10.7-50D215; P10.7-50D230; P10.7-50E215; P10.7-50E230; P10.7-50H190; P10.7-50J180; P10.7-50K190; P10.7-50M175; P10.7-50N160; P10.7-50P175; P10.7-50Q155; P10.7-50U190; P10.7-50V215; P10.7-50V230; P10.7-50X215; P10.7-50X230; P10.7-80A245; P10.7-80A275; P10.7-80A305; P10.7-80A335; P10.7-80A365; P10.7-80B245; P10.7-80B275; P10.7-80B305; P10.7-80B335; P10.7-80B365; P10.7-80C245; P10.7-80C275; P10.7-80C305; P10.7-80C335; P10.7-80C365; P10.7-80D245; P10.7-80D275; P10.7-80D305; P10.7-80D335; P10.7-80D365; P10.7-80E245; P10.7-80E275; P10.7-80E305; P10.7-80E335; P10.7-80E365; P10.7-80V245; P10.7-80V275; P10.7-80V305; P10.7-80V335; P10.7-80V365; P10.7-80X245; P10.7-80X275; P10.7-80X305; P10.7-80X335; P10.7-80X365; Limb lengthening intramedullary rods 12.5 mm diameter: P12.5-30H170; P12.5-30J160; P12.5-30K170; P12.5-30U170; P12.5-50A215; P12.5-50A230; P12.5-50B215; P12.5-50B230; P12.5-50C195; P12.5-50C215; P12.5-50C230; P12.5-50D215; P12.5-50D230; P12.5-50E215; P12.5-50E230; P12.5-50H190; P12.5-50J180; P12.5-50K190; P12.5-50U190; P12.5-50V215; P12.5-50V230; P12.5-50X215; P12.5-50X230; P12.5-80A245; P12.5-80A275; P12.5-80A305; P12.5-80A335; P12.5-80A365; P12.5-80B245; P12.5-80B275; P12.5-80B305; P12.5-80B335; P12.5-80B365; P12.5-80C245; P12.5-80C275; P12.5-80C305; P12.5-80C335; P12.5-80C365; P12.5-80D245; P12.5-80D275; P12.5-80D305; P12.5-80D335; P12.5-80D365; P12.5-80E245; P12.5-80E275; P12.5-80E305; P12.5-80E335; P12.5-80E365; P12.5-80V245; P12.5-80V275; P12.5-80V305; P12.5-80V335; P12.5-80V365; P12.5-80X245; P12.5-80X275; P12.5-80X305; P12.5-80X335; P12.5-80X365; Limb lengthening intramedullary rods 8.5 mm diameter: P8.5-30H170; P8.5-30J160; P8.5-30K170; P8.5-30U170; P8.5-50A215; P8.5-50A230; P8.5-50B215; P8.5-50B230; P8.5-50C195; P8.5-50C215; P8.5-50C230; P8.5-50D215; P8.5-50D230; P8.5-50E215; P8.5-50E230; P8.5-50H190; P8.5-50J180; P8.5-50K190; P8.5-50M165; P8.5-50N150 P8.5-50P165; P8.5-50Q155; P8.5-50U190; P8.5-50V215; P8.5-50V230; P8.5-50X215; P8.5-50X230; P8.5-80A245; P8.5-80A275; P8.5-80A305; P8.5-80A335; P8.5-80A365; P8.5-80B245; P8.5-80B275; P8.5-80B305; P8.5-80B335; P8.5-80B365; P8.5-80C245; P8.5-80C275; P8.5-80C305; P8.5-80C335; P8.5-80C365; P8.5-80D245; P8.5-80D275; P8.5-80D305; P8.5-80D335; P8.5-80D365; P8.5-80E245; P8.5-80E275; P8.5-80E305; P8.5-80E335; P8.5-80E365; P8.5-80V245; P8.5-80V275; P8.5-80V305; P8.5-80V335; P8.5-80V365; P8.5-80X245; P8.5-80X275; P8.5-80X305; P8.5-80X335; P8.5-80X365; Limb lengthening intramedullary rods 10.5 mm diameter: PR10.5-50A215; PR10.5-50A230; PR10.5-50B215; PR10.5-50B230; PR10.5-50C195; PR10.5-50C215; PR10.5-50C230; PR10.5-50D215; PR10.5-50D230; PR10.5-50E215; PR10.5-50E230; PR10.5-80A245; PR10.5-80A275; PR10.5-80A305; PR10.5-80A335; PR10.5-80A365; PR10.5-80B245; PR10.5-80B275; PR10.5-80B305; PR10.5-80B335; PR10.5-80B365; PR10.5-80C245; PR10.5-80C275; PR10.5-80C305; PR10.5-80C335; PR10.5-80C365; PR10.5-80D245; PR10.5-80D275; PR10.5-80D305; PR10.5-80D335; PR10.5-80D365; PR10.5-80E245; PR10.5-80E275; PR10.5-80E305; PR10.5-80E335; PR10.5-80E365; Limb lengthening intramedullary rods 11.5 mm diameter: PR11.5-50A215; PR11.5-50A230; PR11.5-50B215; PR11.5-50B230; PR11.5-50C195; PR11.5-50C215; PR11.5-50C230; PR11.5-50D215; PR11.5-50D230; PR11.5-50E215; PR11.5-50E230; PR11.5-80A245; PR11.5-80A275; PR11.5-80A305; PR11.5-80A335; PR11.5-80A365; PR11.5-80B245; PR11.5-80B275; PR11.5-80B305; PR11.5-80B335; PR11.5-80B365; PR11.5-80C245; PR11.5-80C275; PR11.5-80C305; PR11.5-80C335; PR11.5-80C365; PR11.5-80D245; PR11.5-80D275; PR11.5-80D305; PR11.5-80D335; PR11.5-80D365; PR11.5-80E245; PR11.5-80E275; PR11.5-80E305; PR11.5-80E335; PR11.5-80E365; Limb lengthening intramedullary rods 12.5 mm diameter: PR12.5-50A215; PR12.5-50A230; PR12.5-50B215; PR12.5-50B230; PR12.5-50C195; PR12.5-50C215; PR12.5-50C230; PR12.5-50D215; PR12.5-50D230; PR12.5-50E215; PR12.5-50E230; PR12.5-80A245; PR12.5-80A275; PR12.5-80A305; PR12.5-80A335; PR12.5-80A365; PR12.5-80B245; PR12.5-80B275; PR12.5-80B305; PR12.5-80B335; PR12.5-80B365; PR12.5-80C245; PR12.5-80C275; PR12.5-80C305; PR12.5-80C335; PR12.5-80C365; PR12.5-80D245; PR12.5-80D275; PR12.5-80D305; PR12.5-80D335; PR12.5-80D365; PR12.5-80E245; PR12.5-80E275; PR12.5-80E305; PR12.5-80E335; PR12.5-80E365; Limb lengthening intramedullary rods 9.0 mm diameter: PR9.0-50A215; PR9.0-50A230; PR9.0-50B215; PR9.0-50B230; PR9.0-50C195; PR9.0-50C215; PR9.0-50C230; PR9.0-50D215; PR9.0-50D230; PR9.0-50E215; PR9.0-50E230; PR9.0-80A245; PR9.0-80A275; PR9.0-80A305; PR9.0-80A335; PR9.0-80A365; PR9.0-80B245; PR9.0-80B275; PR9.0-80B305; PR9.0-80B335; PR9.0-80B365; PR9.0-80C245; PR9.0-80C275; PR9.0-80C305; PR9.0-80C335; PR9.0-80C365; PR9.0-80D245; PR9.0-80D275; PR9.0-80D305; PR9.0-80D335; PR9.0-80D365; PR9.0-80E245; PR9.0-80E275; PR9.0-80E305; PR9.0-80E335; PR9.0-80E365; Limb lengthening intramedullary rods 9.5 mm diameter: PR9.5-50A215; PR9.5-50A230; PR9.5-50B215; PR9.5-50B230; PR9.5-50C195; PR9.5-50C215; PR9.5-50C230; PR9.5-50D215; PR9.5-50D230; PR9.5-50E215; PR9.5-50E230; PR9.5-80A245; PR9.5-80A275; PR9.5-80A305; PR9.5-80A335; PR9.5-80A365; PR9.5-80B245; PR9.5-80B275; PR9.5-80B305; PR9.5-80B335; PR9.5-80B365; PR9.5-80C245; PR9.5-80C275; PR9.5-80C305; PR9.5-80C335; PR9.5-80C365; PR9.5-80D245; PR9.5-80D275; PR9.5-80D305; PR9.5-80D335; PR9.5-80D365; PR9.5-80E245; PR9.5-80E275; PR9.5-80E305; PR9.5-80E335; PR9.5-80E365; Trauma intramedullary rods 10.7 mm diameter: T10.7-50A205; T10.7-50A225; T10.7-50A240; T10.7-50B205; T10.7-50B225; T10.7-50B240; T10.7-50C205; T10.7-50C225; T10.7-50C240; T10.7-50D205; T10.7-50D225; T10.7-50D240; T10.7-50E205; T10.7-50E225; T10.7-50E240; T10.7-80A255; T10.7-80A285; T10.7-80A315; T10.7-80A345; T10.7-80A375; T10.7-80B255; T10.7-80B285; T10.7-80B315; T10.7-80B345; T10.7-80B375; T10.7-80C255; T10.7-80C285; T10.7-80C315; T10.7-80C345; T10.7-80C375; T10.7-80D255; T10.7-80D285; T10.7-80D315; T10.7-80D345; T10.7-80D375; T10.7-80E255; T10.7-80E285; T10.7-80E315; T10.7-80E345; T10.7-80E375; Trauma intramedullary rods 12.5 mm diameter: T12.5-50A205; T12.5-50A225; T12.5-50A240; T12.5-50B205; T12.5-50B225; T12.5-50B240; T12.5-50C205; T12.5-50C225; T12.5-50C240; T12.5-50D205; T12.5-50D225; T12.5-50D240; T12.5-50E205; T12.5-50E225; T12.5-50E240; T12.5-80A255; T12.5-80A285; T12.5-80A315; T12.5-80A345; T12.5-80A375; T12.5-80B255; T12.5-80B285; T12.5-80B315; T12.5-80B345; T12.5-80B375; T12.5-80C255; T12.5-80C285; T12.5-80C315; T12.5-80C345; T12.5-80C375; T12.5-80D255; T12.5-80D285; T12.5-80D315; T12.5-80D345; T12.5-80D375; T12.5-80E255; T12.5-80E285; T12.5-80E315; T12.5-80E345; T12.5-80E375; Trauma intramedullary rods 8.5 mm diameter: T8.5-50A205; T8.5-50A225; T8.5-50A240; T8.5-50B205; T8.5-50B225; T8.5-50B240; T8.5-50C205; T8.5-50C225; T8.5-50C240; T8.5-50D205; T8.5-50D225; T8.5-50D240; T8.5-50E205; T8.5-50E225; T8.5-50E240; T8.5-80A255; T8.5-80A285; T8.5-80A315; T8.5-80A345; T8.5-80A375; T8.5-80B255; T8.5-80B285; T8.5-80B315; T8.5-80B345; T8.5-80B375; T8.5-80C255; T8.5-80C285; T8.5-80C315; T8.5-80C345; T8.5-80C375; T8.5-80D255; T8.5-80D285; T8.5-80D315; T8.5-80D345; T8.5-80D375; T8.5-80E255; T8.5-80E285; T8.5-80E315; T8.5-80E345; T8.5-80E375; Locking screws: TSA4.5-020; TSA4.5-025; TSA4.5-030; TSA4.5-035; TSA4.5-040; TSA4.5-045; TSA4.5-050; TSA4.5-055; TSA4.5-060; TSA4.5-065; TSA4.5-070; TSA4.5-075; TSA4-020; TSA4-022.5; TSA4-025; TSA4-027.5; TSA4-030; TSA4-032.5; TSA4-035; TSA4-037.5; TSA4-040; TSA4-042.5; TSA4-045; TSA4-047.5; TSA4-050; TSA4-055; TSA4-060; TSA4-065; TSA4-070; TSA4-075; TSA4-080; TSA4-085; TSA4-090; TSA4-095; TSA4-100; TSA4-100; TSA5-020; TSA5-020; TSA5-022.5; TSA5-022.5; TSA5-025; TSA5-025; TSA5-027.5; TSA5-027.5; TSA5-030; TSA5-030; TSA5-032.5; TSA5-032.5; TSA5-035; TSA5-035; TSA5-037.5; TSA5-037.5; TSA5-040; TSA5-040; TSA5-042.5; TSA5-042.5; TSA5-045; TSA5-045; TSA5-047.5; TSA5-047.5; TSA5-050; TSA5-050; TSA5-052.5; TSA5-055; TSA5-055; TSA5-057.5; TSA5-060; TSA5-060; TSA5-062.5; TSA5-065; TSA5-065; TSA5-067.5; TSA5-070; TSA5-070; TSA5-072.5; TSA5-075; TSA5-075; TSA5-080; TSA5-080; TSA5-085; TSA5-085; TSA5-090; TSA5-090; TSA5-095; TSA5-095; TSA5-100; TSA5-100; TSA5-105; TSA5-105; TSA5-110; TSA5-110; GTIN Numbers: 00812258020002; 00887517001139; 00887517001146; 00887517001153; 00887517001160; 00887517001177; 00887517001184; 00887517001191; 00887517001207; 00887517001214; 00887517001221; 00812258021337; 00812258021344; 00812258021351; 00812258021368; 00812258021375; 00812258021382; 00812258021399; 00812258021405; 00812258021412; 00887517936233; 00887517936240; 00887517936257; 00856719002763; 00856719002770; 00856719002787; 00856719002794; 00856719002800; 00856719002817; 00856719002824; 00856719002831; 00856719002848; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021429; 00812258021436; 00812258021443; 00812258021450; 00812258021467; 00812258021474; 00812258021481; 00812258021498; 00812258021504; 00887517000958; 00887517000965; 00887517000972; 00887517000989; 00887517000996; 00887517001009; 00887517001016; 00887517001023; 00812258021511; 00812258021528; 00812258021535; 00812258021542; 00812258021559; 00812258021566; 00812258021573; 00812258021580; 00812258021597; 00812258021603; 00812258021610; 00812258021627; 00887517001030; 00887517001047; 00887517001054; 00887517001061; 00887517001078; 00812258026073; 00812258026134; 00812258026196; 00812258026257; 00812258020057; 00812258020064; 00812258020231; 00812258020248; 00812258020422; 00812258020439; 00812258020446; 00812258020620; 00812258020637; 00812258020804; 00812258020811; 00812258026080; 00812258026141; 00812258026202; 00812258028244; 00812258028268; 00812258028282; 00812258028220; 00812258026264; 00887517934819; 00887517934826; 00887517934833; 00887517934840; 00812258020071; 00812258020088; 00812258020095; 00812258020101; 00812258020118; 00812258020255; 00812258020262; 00812258020279; 00812258020286; 00812258020293; 00812258020453; 00812258020460; 00812258020477; 00812258020484; 00812258020491; 00812258020644; 00812258020651; 00812258020668; 00812258020675; 00812258020682; 00812258020828; 00812258020835; 00812258020842; 00812258020859; 00812258020866; 00887517934857; 00887517934864; 00887517934871; 00887517934888; 00887517934895; 00887517935502; 00887517935519; 00887517935526; 00887517935533; 00887517935540; 00812258026097; 00812258026158; 00812258026219; 00812258026271; 00812258020125; 00812258020132; 00812258020309; 00812258020316; 00812258020507; 00812258020514; 00812258020521; 00812258020699; 00812258020705; 00812258020873; 00812258020880; 00812258026103; 00812258026165; 00812258026226; 00812258026288; 00887517935557; 00887517935564; 00887517935571; 00887517935588; 00812258020149; 00812258020156; 00812258020163; 00812258020170; 00812258020187; 00812258020323; 00812258020330; 00812258020347; 00812258020354; 00812258020361; 00812258020538; 00812258020545; 00812258020552; 00812258020569; 00812258020576; 00812258020712; 00812258020729; 00812258020736; 00812258020743; 00812258020750; 00812258020897; 00812258020903; 00812258020910; 00812258020927; 00812258020934; 00887517935595; 00887517935601; 00887517935618; 00887517935625; 00887517935632; 00887517935649; 00887517935656; 00887517935663; 00887517935670; 00887517935687; 00812258026059; 00812258026110; 00812258026172; 00812258026233; 00812258020019; 00812258020026; 00812258020194; 00812258020200; 00812258020378; 00812258020385; 00812258020392; 00812258020583; 00812258020590; 00812258020767; 00812258020774; 00812258026066; 00812258026127; 00812258026189; 00812258028237; 00812258028251; 00812258028275; 00812258028213; 00812258026240; 00887517935694; 00887517935700; 00887517935717; 00887517935724; 00812258020033; 00812258020040; 00812258022358; 00812258022365; 00812258022372; 00812258020217; 00812258020224; 00812258022389; 00812258022396; 00812258022402; 00812258020408; 00812258020415; 00812258022419; 00812258022426; 00812258022433; 00812258020606; 00812258020613; 00812258022440; 00812258022457; 00812258022464; 00812258020781; 00812258020798; 00812258022471; 00812258022488; 00812258022495; 00887517935731; 00887517935748; 00887517935755; 00887517935762; 00887517935779; 00887517935786; 00887517935793; 00887517935809; 00887517935816; 00887517935823; 00812258025359; 00812258025366; 00812258024253; 00812258024260; 00812258024956; 00812258024963; 00812258024970; 00812258024604; 00812258024611; 00812258025700; 00812258025717; 00812258025373; 00812258025380; 00812258025397; 00812258025403; 00812258025410; 00812258024277; 00812258024284; 00812258024291; 00812258024307; 00812258024314; 00812258024987; 00812258024994; 00812258025007; 00812258025014; 00812258025021; 00812258024628; 00812258024635; 00812258024642; 00812258024659; 00812258024666; 00812258025724; 00812258025731; 00812258025748; 00812258025755; 00812258025762; 00812258025427; 00812258025434; 00812258024321; 00812258024338; 00812258025038; 00812258025045; 00812258025052; 00812258024673; 00812258024680; 00812258025779; 00812258025786; 00812258025441; 00812258025458; 00812258025465; 00812258025472; 00812258025489; 00812258024345; 00812258024352; 00812258024369; 00812258024376; 00812258024383; 00812258025069; 00812258025076; 00812258025083; 00812258025090; 00812258025106; 00812258024697; 00812258024703; 00812258024710; 00812258024727; 00812258024734; 00812258025793; 00812258025809; 00812258025816; 00812258025823; 00812258025830; 00812258025632; 00812258025649; 00812258024390; 00812258024406; 00812258025113; 00812258025120; 00812258025137; 00812258024741; 00812258024758; 00812258025984; 00812258025991; 00812258025656; 00812258025663; 00812258025670; 00812258025687; 00812258025694; 00812258024413; 00812258024420; 00812258024437; 00812258024444; 00812258024451; 00812258025144; 00812258025151; 00812258025168; 00812258025175; 00812258025182; 00812258024765; 00812258024772; 00812258024789; 00812258024796; 00812258024802; 00812258026004; 00812258026011; 00812258026028; 00812258026035; 00812258026042; 00812258025496; 00812258025502; 00812258024468; 00812258024475; 00812258025199; 00812258025205; 00812258025212; 00812258024819; 00812258024826; 00812258025847; 00812258025854; 00812258025519; 00812258025526; 00812258025533; 00812258025540; 00812258025557; 00812258024482; 00812258024499; 00812258024505; 00812258024512; 00812258024529; 00812258025229; 00812258025236; 00812258025243; 00812258025250; 00812258025267; 00812258024833; 00812258024840; 00812258024857; 00812258024864; 00812258024871; 00812258025861; 00812258025878; 00812258025885; 00812258025892; 00812258025908; 00812258025564; 00812258025571; 00812258024536; 00812258024543; 00812258025274; 00812258025281; 00812258025298; 00812258024888; 00812258024895; 00812258025915; 00812258025922; 00812258025588; 00812258025595; 00812258025601; 00812258025618; 00812258025625; 00812258024550; 00812258024567; 00812258024574; 00812258024581; 00812258024598; 00812258025304; 00812258025311; 00812258025328; 00812258025335; 00812258025342; 00812258024901; 00812258024918; 00812258024925; 00812258024932; 00812258024949; 00812258025939; 00812258025946; 00812258025953; 00812258025960; 00812258025977; 00812258023836; 00812258023843; 00812258023850; 00812258023119; 00812258023126; 00812258023133; 00812258023591; 00812258023607; 00812258023614; 00812258023355; 00812258023362; 00812258023379; 00812258024079; 00812258024086; 00812258024093; 00812258023867; 00812258023874; 00812258023881; 00812258023898; 00812258023904; 00812258023140; 00812258023157; 00812258023164; 00812258023171; 00812258023188; 00812258023621; 00812258023638; 00812258023645; 00812258023652; 00812258023669; 00812258023386; 00812258023393; 00812258023409; 00812258023416; 00812258023423; 00812258024109; 00812258024116; 00812258024123; 00812258024130; 00812258024147; 00812258023911; 00812258023928; 00812258023935; 00812258023195; 00812258023201; 00812258023218; 00812258023676; 00812258023683; 00812258023690; 00812258023430; 00812258023447; 00812258023454; 00812258024154; 00812258024161; 00812258024178; 00812258023942; 00812258023959; 00812258023966; 00812258023973; 00812258023980; 00812258023225; 00812258023232; 00812258023249; 00812258023256; 00812258023263; 00812258023706; 00812258023713; 00812258023720; 00812258023737; 00812258023744; 00812258023461; 00812258023478; 00812258023485; 00812258023492; 00812258023508; 00812258024185; 00812258024192; 00812258024208; 00812258024215; 00812258024222; 00812258023751; 00812258023768; 00812258023775; 00812258023034; 00812258023041; 00812258023058; 00812258023515; 00812258023522; 00812258023539; 00812258023270; 00812258023287; 00812258023294; 00812258023997; 00812258024000; 00812258024017; 00812258023782; 00812258023799; 00812258023805; 00812258023812; 00812258023829; 00812258023065; 00812258023072; 00812258023089; 00812258023096; 00812258023102; 00812258023546; 00812258023553; 00812258023560; 00812258023577; 00812258023584; 00812258023300; 00812258023317; 00812258023324; 00812258023331; 00812258023348; 00812258024024; 00812258024031; 00812258024048; 00812258024055; 00812258024062; 00887517936011; 00887517936028; 00887517936035; 00887517936042; 00887517936059; 00887517936066; 00887517936073; 00887517936080; 00887517936097; 00887517936202; 00887517936219; 00887517936226; 00887517000033; 00887517000040; 00887517000057; 00887517000064; 00887517000071; 00887517000088; 00887517000095; 00887517000101; 00887517000118; 00887517000125; 00887517000132; 00887517000149; 00887517000156; 00887517000163; 00887517000170; 00887517000187; 00887517000194; 00887517000200; 00887517000217; 00887517000224; 00887517000231; 00887517000248; 00887517000255; 00887517000255; 00812258027728; 00887517000262; 00812258027735; 00887517000279; 00812258027742; 00887517000286; 00812258027759; 00887517000293; 00812258027766; 00887517000309; 00812258027773; 00887517000316; 00812258027780; 00887517000323; 00812258027797; 00887517000330; 00812258027803; 00887517000347; 00812258027810; 00887517000354; 00812258027827; 00887517000361; 00812258027834; 00887517000378; 00812258027841; 00887517000385; 00812258027858; 00812258027865; 00887517000392; 00812258027872; 00812258027889; 00887517000408; 00812258027896; 00812258027902; 00887517000415; 00812258027919; 00812258027926; 00887517000422; 00812258027933; 00812258027940; 00887517000439; 00812258027957; 00887517000446; 00812258027964; 00887517000453; 00812258027971; 00887517000460; 00812258027988; 00887517000477; 00812258027995; 00887517000484; 00812258028008; 00812258028008; 00812258028015; 00812258028015;
Where was it sold?
Worldwide distribution, including U.S. Nationwide.
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
2 other products · FDA event 87353This product is part of a recall event; the main page for the event is Nuvasive Precice Unyte System (Humerus and Tibia) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nuvasive Precice Unyte System (Humerus and Tibia) recalled | Nuvasive Specialized Orthopedics | Other | Nationwide | |
| CLASS II | Nuvasive Freedom: End Cap for Precice Intramedullary Limb recalled | Nuvasive Specialized Orthopedics | Packaging Defects | Nationwide |
More recalls from Nuvasive Specialized Orthopedics
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Precice Max recalled by NuVasive Specialized | NuVasive Specialized Orthopedics | Other | FL, NV |
| Device | CLASS II | Nuvasive Magec 2 Rod recalled by NuVasive Specialized | NuVasive Specialized Orthopedics | Sterility | Nationwide |
| Device | CLASS II | Magec 1 System recalled by NuVasive Specialized | NuVasive Specialized Orthopedics | Other | CA |
| Device | CLASS II | Nuvasive Freedom: End Cap for Precice Intramedullary Limb recalled | Nuvasive Specialized Orthopedics | Packaging Defects | Nationwide |
| Device | CLASS II | Nuvasive Precice Unyte System (Humerus and Tibia) recalled | Nuvasive Specialized Orthopedics | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |