Drug recall
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup…
FDA recall event 95653 · Class II · INCIPIO DEVICES
Key facts
| Event ID | 95653 |
|---|---|
| Recall numbers | Z-0549-2025 |
| Recalling firm | INCIPIO DEVICES |
| Product type | Devices |
| Products | Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. |
| Initiation date | Oct 30, 2024 |
| Report date | Dec 4, 2024 |
| City | St-Blaise |
| Country | Switzerland |
| FEI number | 3013223655 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: