Tiger Cannulated Tray Lid Part # NON-STERILE 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 Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE;…

Recall number

Z-2464-2015

FDA classification

Class II

Brand / firm

Trilliant Surgical Ltd.

Sold / distributed

Nationwide Distribution

Why it was recalled

Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.

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 Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless 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.