Recall Z-0549-2025— INCIPIO DEVICES
Class II · Ongoing
Class II FDA medical device recall by INCIPIO DEVICES, initiated 2024-10-30. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- INCIPIO DEVICES
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-30
- Firm location
- St-Blaise, Switzerland
Product description
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Reason for recall
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Data sourced from openFDA. This site is unofficial and independent of the FDA.