FDA (Devices) recall action 91073
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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 femor…
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zimmer Biomet is voluntarily recalling 284 NexGen tibial knee components due to higher revision rates when paired with specific femoral components. Patients with these implant combinations should contact their surgeon.
Zimmer Biomet is recalling NexGen Option Stemmed Tibial knee components (2,092 units) due to clinically significant higher revision rates when used with specific femoral components. The voluntary recall prevents future implantation with these problematic combinations.
Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.
Zimmer is voluntarily recalling NexGen Option Stemmed Tibial Component Size 7 (1,049 units) due to higher-than-expected revision rates when used with specific femoral components, based on UK registry data.
Zimmer Inc. is recalling NexGen Option Stemmed Tibial Components due to clinically and statistically significant higher revision rates when used with specific femoral components. The components are being removed from inventory.
Zimmer is recalling NexGen Option Stemmed Tibial Components due to clinically significant higher revision rates when used with specific femoral components. Patients should contact their surgeon to discuss their implant.