Recall Z-2500-2020— XTANT Medical
Class II · Terminated
Class II FDA medical device recall by XTANT Medical, initiated 2020-05-12, terminated 2021-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591. Reason: The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld..
- Recalling firm
- XTANT Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-12
- Terminated
- 2021-03-19
- Firm location
- Belgrade, MT, United States
Product description
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Reason for recall
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
Data sourced from openFDA. This site is unofficial and independent of the FDA.