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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Electric Pen Drive (EPD) System

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  Class 2 Device Recall Synthes Electric Pen Drive (EPD) System see related information
Date Initiated by Firm December 19, 2014
Date Posted March 23, 2015
Recall Status1 Terminated 3 on May 19, 2016
Recall Number Z-1313-2015
Recall Event ID 70247
510(K)Number K043310  
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product 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 Part Number  05.001.012  Lot Numbers AV18166 AV19044 AV20666  
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Process design
Action 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 FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 249
Distribution Nationwide Distribution
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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