Recall Z-2500-2020 ยท HWA Impactor
XTANT Medical
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
| Date | May 12, 2020 |
| Status | Terminated |
| Reason | The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 4 units |
| Distribution | AZ, TX and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.