Trilliant Surgical Ltd. recalls Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indi…

Recall date

December 8, 2016

Source

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

Recall number

Z-0960-2017

FDA classification

Class II

Brand / firm

Trilliant Surgical Ltd.

Sold / distributed

Nationwide Distribution

Why it was recalled

Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.

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

What was recalled

Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.