Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
This recall has been terminated (originally issued May 12, 2020).
- Company
- Xtant Medical
- Recall Initiated
- May 12, 2020
- Terminated
- March 19, 2021
- Recall Number
- Z-2500-2020
- Quantity
- 4 units
- Firm Location
- Belgrade, MT
- Official Source
- View on FDA website ↗
Reason for Recall
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
Distribution
AZ, TX and WV.
Lot / Code Info
LOT: XS1920458A
Root Cause
Process design
Action Taken
On May 12, 2020 a customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to the three customers who received the affected devices. On May 19, 2020, an additional customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to one of the three affected customers.