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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Implant Holder for Synfix (TM)LR

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  Class 2 Device Recall Synthes Implant Holder for Synfix (TM)LR see related information
Date Initiated by Firm October 08, 2013
Date Posted November 27, 2013
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-0405-2014
Recall Event ID 66577
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Synthes Implant Holder for Synfix (TM)-LR

the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
Code Information all lots of part no. 03.802.039
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 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 returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 548
Distribution Worldwide Distribution - USA (nationwide) and Internationally to 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.
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