Trilliant Surgical Ltd. recalls Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex R…

Recall date

July 20, 2015

Source

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

Recall number

Z-2456-2015

FDA classification

Class II

Brand / firm

Trilliant Surgical Ltd.

Sold / distributed

Nationwide throughout the US

Why it was recalled

The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.

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

What was recalled

Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.