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.
- Company
- Trimed Inc.
- Recall Initiated
- September 28, 2018
- Recall Number
- Z-0359-2020
- Quantity
- 561 devices
- Firm Location
- Santa Clarita, CA
Reason for Recall
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Distribution
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Lot / Code Info
Lot numbers 049045, 049044, and 049044R1.
Root Cause
Nonconforming Material/Component
Action Taken
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.
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