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Recall Observatory FDA recall evidence

Device product

Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile

Z-2338-2018

March 27, 2018

Class II

Product summary

Firm
Trilliant Surgical Ltd.
Event
Event 80195
Status
Terminated
Classification
Class II
Quantity
94
Official record key
device-enforcement:Z-2338-2018

Official wording

Reason: Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.

Code information: Lot: 603599

Distribution pattern: U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.