Recall Z-1373-2018 ยท LXH Orthopedic Manual Surgical Instrument
TriMed Inc.
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
| Date | Jan 11, 2018 |
| Status | Terminated |
| Reason | Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy. |
| Root cause | Process control |
| Action | Recall notification letters were sent to affected consignees on January 16, 2018. The consignee letter requests that the consignee return an initial Acknowledgement & Receipt Form to TriMed by January 23, 2018. |
| Quantity | 1525 devices |
| Distribution | US, China, Latin America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.