Knee implant tibial component recalled for higher revision rates
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.
What this means for you
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: FDA Class II medical device recall based on registry data demonstrating higher clinical revision rates, but no patient injuries or illnesses are reported in the source. Qualifies as a risk-of-harm product where increased failure risk is documented in clinical evidence without reported patient harm.
Plain-English summary
Zimmer Biomet is conducting a voluntary recall of the NexGen Option Stemmed Tibial Component Size 8 (Item Number 00-5986-057-02), a knee replacement component. The recall involves 284 units that were distributed worldwide, including throughout the United States.
The device is being recalled because it shows clinically and statistically significant higher overall revision rates when used with either the LPS Flex or LPS Flex Gender Solutions Femoral (GSF) components, compared to other total knee replacement systems documented in the United Kingdom National Joint Registry.
Patients who have received this tibial component paired with either of the two specified femoral components should contact their surgeon or healthcare provider for evaluation. Zimmer Biomet recommends removing any remaining inventory of this component to prevent future implantation with these specific femoral combinations.
The recalled product
- Product
- NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
- Manufacturer
- Zimmer, Inc.
- Hazard
- implant-failure
- high-revision-rate
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.
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