Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes Electric Pen Drive (EPD) System Recalled by Synthes, Inc. Due to In May 2013, the original recall was initiated...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synthes, Inc. directly.
Affected Products
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.
Quantity: 249
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synthes, Inc.
Synthes, Inc. has 43 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report