Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw in...
FDA Recall #Z-1313-2015 — Class II — December 19, 2014
Product Description
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.
Reason for Recall
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.
Recalling Firm
Synthes, Inc. — West Chester, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
249
Distribution
Nationwide Distribution
Code Information
Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated