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.
FDA Recall Z-0359-2020 · Posted None
Recalling FirmTriMed Inc.
Recall StatusOpen, Classified
Product CodeLXH
Date Initiated2018-09-28
Product Quantity561 devices
Reason for Recall
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.