Class II — INCIPIO DEVICES
| Recalling firm | Incipio Devices |
|---|---|
| Registered facility | INCIPIO DEVICES (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. |
| Product | Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants. |
| Quantity | 100 units |
| Distribution | US Nationwide distribution in the state of TN. |
| Initiated | 2024-10-30 |
| Classified | 2024-11-25 |
| Recall number | Z-0549-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — INCIPIO DEVICES (Z-0549-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95653/
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