Device product
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.
Z-0359-2020
Product summary
- Firm
- TriMed Inc.
- Event
- Event 83820
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 561 devices
- Official record key
device-enforcement:Z-0359-2020
Official wording
Reason: The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Code information: Lot numbers 049045, 049044, and 049044R1.
Distribution pattern: Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Derived failure modes
-
Unknown
The WHD/WHV impactors can rust over time due to an improper manufacturing process.