Z-1313-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2015
- Initiation Date
- December 19, 2014
- Termination Date
- May 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 249
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.
Distribution Pattern
Nationwide Distribution
Code Information
Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666