7 Hole VL Gridlock Fibula Plate recalled over sterility concerns

Recall date

August 6, 2015

Source

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

Official notice title

Trilliant Surgical Ltd. recalls 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part #…

Recall number

Z-2490-2015

FDA classification

Class II

Brand / firm

Trilliant Surgical Ltd.

Sold / distributed

US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.

Why it was recalled

The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws.

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

What was recalled

7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.