FDAFDA · Food and drugs·Recall number Z-1313-2015
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.
Published April 1, 2015 · Recall initiated: December 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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