Synthes, Inc. recalls 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm ther…

Recall date

May 13, 2015

Source

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

Recall number

Z-1711-2015

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and Canada.

Why it was recalled

affected parts and lots of the Cannulated Drill Bits have the potential to break during use

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

What was recalled

3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.