Z-2500-2020 Class II Terminated
FDA device recall Z-2500-2020 was initiated by XTANT Medical on May 12, 2020 and is designated Class II. Reason for recall: The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld. The recall status is terminated (terminated March 19, 2021). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- May 12, 2020
- Termination Date
- March 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
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.
Distribution Pattern
AZ, TX and WV.
Code Information
LOT: XS1920458A