RegWardenFDA facility compliance records
Recall

Class II — Trilliant Surgical Ltd.

Recalling firmTrilliant Surgical
Registered facilityTrilliant Surgical LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonFirm 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.
ProductCannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
Quantity94
DistributionU.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO
Initiated2018-03-27
Classified2018-07-02
Terminated2020-06-04
Recall numberZ-2338-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Trilliant Surgical Ltd. (Z-2338-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80195/

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