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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Trochanteric Fixation Nail

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 Class 2 Recall
Synthes Trochanteric Fixation Nail
see related information
Date Posted December 10, 2013
Recall Status1 Open
Recall Number Z-0474-2014
Recall Event ID 66409
Premarket Notification
510(K) Number
K011857 
Product Classification Rod, Fixation, Intramedullary And Accessories - Product Code HSB
Product Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Code Information Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.
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
Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 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 take the following actions: Call Syntehs at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section checking the appropriate box indicating affected product has been located. Return the Verfication Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If no affected product found customers were instructed to take the following steps: Complete the attached Verification Section at the end of the letter by checking the appropriate box indicating no affected product has been located. Return the documents to Synthes by fax to 610-251-9005 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 12
Distribution Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = SYNTHES (USA)
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