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FDADecember 19, 2014device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

synthes

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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