FDA Device recall Z-0281-2025
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015 by Smith And Nephew, citing complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0281-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-02 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smith And Nephew |
| Distribution | AL, CA, DE, GA, MS, NC, TN |
Product
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Reason
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Identifiers
| code_info | UDI/DI 03596010469212, Batch number 23LM02331 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0281-2025%22
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