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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Hand Switch Electric Pen Drive

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  Class 2 Device Recall Synthes Hand Switch Electric Pen Drive see related information
Date Initiated by Firm April 15, 2013
Date Posted December 31, 2013
Recall Status1 Terminated 3 on September 14, 2016
Recall Number Z-0615-2014
Recall Event ID 65007
510(K)Number K043310  
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product 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 Part Number 05.001.012, lot number AV18166
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Synthes Customer Service
610-719-5000
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 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 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: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450 or email FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 290
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWE and Original Applicant = SYNTHES (USA)
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