NexGen LPS Flex — Class II medical device recall Z-1433-2025
Ongoing recall by Zimmer, Inc., reported 2025-04-02, distributed nationwide. The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibi
| Recall number | Z-1433-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2025-02-27 |
| Classified | 2025-03-24 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, IN, NL, SG |
| Quantity | 76 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889024666214 |
| Lot numbers | 66789408, 66792792 |
| Model numbers | 00-5962-042-10 |
Product
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Reason for recall
The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1433-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.