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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 Recall
Synthes Implant Holder for Synfix (TM)LR
see related information
Date Posted November 27, 2013
Recall Status1 Open
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, Pennsylvania 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.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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