FDA Device recall Z-0615-2014

Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and w…

• FDA Device
• Class II
• terminated
• Published 2014-01-08

On 2014-01-08 the FDA classified a Class II recall of Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and w… by Synthes Usa Hq, citing 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.

Read the official FDA Device notice

Product

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.

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0615-2014%22

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