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Recall Observatory FDA recall evidence

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

September 28, 2018

Class II

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

    reason.no_named_rule · v1.0.0

    The WHD/WHV impactors can rust over time due to an improper manufacturing process.