Zimmer Recalls NexGen Stemmed Tibial Components Due to Higher Revision Rates
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prosthetic joint component with documented, statistically significant higher revision rates when used with specific femoral components, indicating increased device failure. No specific patient injuries or hospitalizations have been reported in the source material.
Plain-English summary
Zimmer, Inc. is conducting a voluntary recall of the NexGen Option Stemmed Tibial Component Size 5 (Item Number 00-5986-047-01). Approximately 2,460 units have been distributed nationwide and worldwide to hospitals and medical facilities. The recall applies to all unexpired lots.
The recall is due to clinically and statistically significant higher overall revision rates observed in the United Kingdom National Joint Registry (UK NJR) when these tibial components are used in combination with either the Legacy Posterior Stabilized (LPS) Flex Femoral components or the LPS Flex Gender Solutions Femoral (GSF) components. These revision rates are higher compared to other total knee arthroplasty combinations.
Healthcare providers and facilities are instructed to remove this component from inventory immediately to prevent any future implantation with the LPS Flex or LPS Flex GSF femoral components. Zimmer is taking this action to mitigate the increased revision risk associated with these specific component combinations.
The recalled product
- Product
- NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 2,460
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Unexpired Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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