FDA Device recall Z-1036-2023
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, inc…
- FDA Device
- Class II
- ongoing
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, inc… by Biomet, citing product missing the four small locking collar bolts resulting in extension of surgery to find a replacement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1036-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-29 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomet |
| Distribution | US |
Product
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
Reason
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Identifiers
| code_info | UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1036-2023%22
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