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Synthes Hand Switch - Electric Pen Drive, Part Number… recallZ-0615-2014 · Synthes USA HQ, Inc. · initiated Apr 15, 2013

Class II Terminated All recalls posted in December 2013

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 USA HQ, 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

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.

FDA root cause category: Process design

What the company is doing

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 located. Return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should still complete the Verifcation Section at the end of the letter by checking the appropriate box and faxing the document to 610-251-9005 or email to: [email protected] 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-0615-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 15, 2013
Posted by the FDA
Dec 31, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
290
Product code
HWE
FDA submissions
K043310
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .

Product description

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.

Code information (models, lots, serial numbers)

Part Number 05.001.012, lot number AV18166

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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