Zimmer, Inc. Recall 91073
Description: NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Zimmer, Inc. Recall 91073 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0470-2023 |
| Event ID | 91073 |
| Event Description | NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution. |
| Quantity | 1049 |
| Recall 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. |
| Device Classification | 20221221 |
| Device Code Info | All Unexpired Lots |
| Center Classification Date | 20221209 |
| Recall Initiation Date | 20221206 |
| Recalling Firm | Zimmer, Inc. |
| Initial Notification | Letter |
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