Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes Hand Switch - Electric Pen Drive Recalled by Synthes USA HQ, Inc. Due to Synthes received a complaint from a customer in...
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 USA HQ, Inc. directly.
Affected Products
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.
Quantity: 290
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synthes USA HQ, Inc.
Synthes USA HQ, Inc. has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report