Trilliant Surgical Ltd. recalls Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile

Recall date

March 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2338-2018

FDA classification

Class II

Brand / firm

Trilliant Surgical Ltd.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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