Recall Z-0615-2014 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Synthes USA HQ, Inc.
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, o
| Date | Dec 31, 2013 (initiated Apr 15, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Process design |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product, remove from inventory, and return them to Synthes immediately for replacement. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been loc |
| Quantity | 290 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM Synthes (Usa), Jan 5, 2005 |