FDA Device recall Z-1038-2025
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
- FDA Device
- Class II
- ongoing
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class II recall of NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14 by Zimmer, citing it was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units wi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1038-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-06 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zimmer |
| Distribution | US |
Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Reason
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Identifiers
| code_info | UDI-DI: 00889024635647; Lot Numbers: 66602503 66520665 66881918 66949906 |
|---|
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-1038-2025%22
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