Synthes, Inc. recalls Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire…

Recall date

December 19, 2014

Source

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

Recall number

Z-1313-2015

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.

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

What was recalled

Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.