FDA-Device2019-11-20Class II
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.
TriMed Inc.
Hazard
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Sold states
Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Affected count
561 devices
Manufactured in
27533 Avenue Hopkins, N/A, Santa Clarita, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0359-2020Don't want to check this manually?
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