Synthes, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1313-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 19, 2014

Date Posted: April 1, 2015

Recall Number: Z-1313-2015

Event ID: 70247

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.

Status: Terminated

Product Quantity: 249

Code Information:

Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated