FDA Device recall Z-0549-2025
Offset Cup Impactor - 3/8-16 interface
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of Offset Cup Impactor - 3/8-16 interface by Incipio Devices, citing recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0549-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-30 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Incipio Devices |
| Distribution | US |
Product
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Reason
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Identifiers
| code_info | Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087. |
|---|
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-0549-2025%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.