Recall Z-0359-2020 ยท LXH Orthopedic Manual Surgical Instrument
TriMed Inc.
TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.
| Date | Sep 28, 2018 |
| Status | Open, Classified |
| Reason | The WHD/WHV impactors can rust over time due to an improper manufacturing process. |
| 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 | 561 devices |
| 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.