FDA Device recall Z-1329-2025
Z1 Femoral Hip System, Product Number 611777612
- FDA Device
- Class II
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of Z1 Femoral Hip System, Product Number 611777612 by Zimmer, citing there is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1329-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-12 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Z1 Femoral Hip System, Product Number 611777612
Reason
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
Identifiers
| code_info | UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277 |
|---|
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-1329-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.