FDA Devices recall · Reported December 21, 2022
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
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 ove…
Zimmer, Inc. recalled NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 - a moderate-severity action.
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 was recalled by Zimmer, Inc. in December 21, 2022. Reason: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Com…. Check the official notice for the remedy. Verify recall #Z-0466-2023 with the FDA Devices before acting.
The recall
Zimmer, Inc. issued this moderate-severity FDA Devices recall-Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Com….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- December 21, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0466-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0466-2023) was formally reported on December 21, 2022, with the manufacturer initiating the action on December 6, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Zimmer, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 1673.
The documented reason for this recall is: 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 co… Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0466-2023 |
| Date reported | December 21, 2022 |
| Date initiated | December 6, 2022 |
| Recalling firm | Zimmer, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 1673 |
| Distribution | Worldwide - US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0466-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026