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Recall Observatory FDA recall evidence

Device product

TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Z-0355-2020

September 28, 2018

Class II

Product summary

Firm
TriMed Inc.
Event
Event 83820
Status
Ongoing
Classification
Class II
Quantity
99 instruments
Official record key
device-enforcement:Z-0355-2020

Official wording

Reason: The epoxy on Apex manufactured epoxy-coated instruments can pop off.

Code information: Lot number 91401455

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 epoxy on Apex manufactured epoxy-coated instruments can pop off.