Trilliant Surgical product recalled over sterility concerns

Recall date

July 31, 2015

Source

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

Official notice title

Trilliant Surgical Ltd. recalls 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use wit…

Recall number

Z-2738-2015

FDA classification

Class II

Brand / firm

Trilliant Surgical Ltd.

Sold / distributed

NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX

Why it was recalled

Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head.

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

What was recalled

2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.