Z-0466-2023 Class II Ongoing
FDA device recall Z-0466-2023 was initiated by Zimmer, Inc. on Dec 6, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1673.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Dec 6, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1673
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
All Unexpired Lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0466-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026