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Synthes Electric Pen Drive (EPD) System, The Synthes… recallZ-1313-2015 · Synthes, Inc. · initiated Dec 19, 2014

Class II Terminated All recalls posted in March 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process design

What the company is doing

Synthes sent an Urgent Medical Device Recall Notice, dated December 19, 2014, to all affected customers to provide updated information on additional lots identified. 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 to obtain a Return Authorization (RA) Number, complete the Verification Section at the end of the letter, and return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email [email protected]. For questions regarding this recall call 610-719-5000.

Recall details

Recall number
Z-1313-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 19, 2014
Posted by the FDA
Mar 23, 2015
Recalling firm
Synthes, Inc.
Quantity
249
Product code
HWE
FDA submissions
K043310
Distribution
Nationwide Distribution

Product description

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.

Code information (models, lots, serial numbers)

Part Number  05.001.012  Lot Numbers AV18166 AV19044 AV20666

Other devices under the same FDA submission

66 devices cleared under K043310 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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