Synthes USA HQ, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0615-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 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: April 15, 2013

Date Posted: January 8, 2014

Recall Number: Z-0615-2014

Event ID: 65007

Reason for Recall:

Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.

Status: Terminated

Product Quantity: 290

Code Information:

Part Number 05.001.012, lot number AV18166

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .

Voluntary or Mandated:

Voluntary: Firm initiated