FDA Device recall Z-0468-2023
NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
- FDA Device
- Class II
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 by Zimmer, citing 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 ove….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0468-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-06 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Zimmer |
| Distribution | US |
Product
NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
Reason
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.
Identifiers
| code_info | All Unexpired Lots |
|---|
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-0468-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.