Trilliant Surgical product recalled over sterility concerns

Recall date

July 20, 2015

Source

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

Official notice title

Trilliant Surgical Ltd. recalls 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-…

Recall number

Z-2421-2015

FDA classification

Class II

Brand / firm

Trilliant Surgical Ltd.

Sold / distributed

US Nationwide Distribution in the states of: NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI and MD.

Why it was recalled

The cutting efficiency of the Countersinks was out of specification.

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

What was recalled

2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.