Device product
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.
Z-1313-2015
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 70247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 249
- Official record key
device-enforcement:Z-1313-2015
Official wording
Reason: 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.
Code information: Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.