Recall Z-0357-2020 ยท LXH Orthopedic Manual Surgical Instrument
TriMed Inc.
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
| Date | Sep 28, 2018 |
| Status | Open, Classified |
| Reason | The epoxy on Apex manufactured epoxy-coated instruments can pop off. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued letters via email on 9/28/2018 explaining the reason for recall and requesting consignees to identify potentially-affected product and quarantine it until a TriMed representative is able to conduct an inspection. |
| Quantity | 467 hex drivers |
| Distribution | Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.