Zimmer recalls NexGen Stemmed Tibial Component Size 7 due to higher revision rates when used with specific LPS Flex femoral components in UK joint registry data. Affected patients should contact Zimmer for guidance.
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.
Take action
Contact the company
📍Recalling firmZimmer, Inc.1800 W Center St · Warsaw, IN 46580-2304
“Zimmer NexGen Stemmed Tibial Component Recall: Higher Revision Risk with LPS Flex.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59229-zimmer-nexgen-stemmed-tibial-component-recall-higher-revision-risk-with. Based on FDA recall #Z-0470-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0470-2023%22&limit=1).
The FDA announced on Dec. 6, 2022, that Zimmer, Inc. is recalling NexGen Option Stemmed Tibial Component Size 7 due to higher revision rates when used with specific femoral components. Owners should remove the product from inventory to prevent future implantation.
The recall addresses clinically and statistically significant higher overall revision rates when the tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components compared to other total knee arthroplasties in the United Kingdom National Joint Registry. Removing the component from inventory prevents its future implantation and mitigates this increased revision risk.
Context
GovInfoNow's records show Zimmer, Inc. has had 19 other recalls since Aug. 25, 2022. Other recent recalls of similar products include Howmedica DURACON XL Angled Tibial Implants Recall (July 30, 2026), Howmedica SCORPIO Patella Implants Recall (July 30, 2026), and Howmedica Osteonics Recalls Knee Implant Components Due to Oxidation Risk (July 30, 2026).
How to tell if you have this one
Check if your knee implant is labeled 'NexGen Option Stemmed Tibial Component Size 7' with item number 00-5986-057-01. The recall applies to all unexpired lots of this component.
Brand
Zimmer
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-0466-2023
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01; All Unexpired Lots
1673
Z-0467-2023
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02; All Unexpired Lots
2092
Z-0468-2023
NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01; All Unexpired Lots
2460
Z-0469-2023
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02; All Unexpired Lots
1366
Z-0470-2023
NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01; All Unexpired Lots
1049
Z-0471-2023
NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02; All Unexpired Lots
284
Based on the official FDA remedy
What to do — step by step
Contact Zimmer
Reach out to Zimmer directly for guidance on next steps after recalling your implant.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 15 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0470-2023 (December 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0470-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.