NexGen Option Stemmed Tibial Component Size 7 — Class II medical device recall Z-0470-2023
Ongoing recall by Zimmer, Inc., reported 2022-12-21, distributed nationwide. Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Comp
| Recall number | Z-0470-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2022-12-06 |
| Classified | 2022-12-09 |
| Reported by FDA | 2022-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,049 |
| Model numbers | 00-5986-057-01 |
Product
NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Reason for recall
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0470-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.