Synthes, Inc. recalls 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting M…

Recall date

December 15, 2014

Source

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

Recall number

Z-1021-2015

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

Worldwide Distribution -- US and Canada.

Why it was recalled

Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.

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 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.