CLASS II ONGOING Device recall · Reported 8 Feb 2023 · FDA Enforcement Report
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly recalled
Biomet is recalling OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the, distributed nationwide in the US. The recall was initiated on 29 Nov 2022 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-1036-2023
- FDA event ID
- 91423
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Nov 2022
- FDA classified
- 27 Jan 2023
- Reported
- 8 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 29 Nov 2022 | Recall initiated by company | |
| 27 Jan 2023 | Classified by FDA | +59 days |
| 8 Feb 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
Where it was distributed
US Nationwide distribution in the states of CA, KY, FL.
Questions about this recall
Is OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the recalled?
Yes. Biomet recalled OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the on 29 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-1036-2023.
Why was it recalled?
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Which lots are affected?
UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620
Where was it sold?
US Nationwide distribution in the states of CA, KY, FL.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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