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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Titanium Cannulated Humeral Nail

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  Class 2 Device Recall Synthes Titanium Cannulated Humeral Nail see related information
Date Initiated by Firm July 30, 2013
Date Posted November 27, 2013
Recall Status1 Terminated 3 on September 10, 2015
Recall Number Z-0407-2014
Recall Event ID 66419
510(K)Number K033071  
Product Classification Nail, fixation, bone - Product Code JDS
Product Synthes Titanium Cannulated Humeral Nail

Intended to aid in the alignment and stabilization of humeral fractures
Code Information Part # Lot #    04.001.620S 7115414  04.001.620S 7115417  04.001.620S 7115509  04.001.620S 7115510  04.001.622S 7115533  04.001.636S 7117902  04.001.636S 7117916  04.001.638S 7117924  04.001.640S 7119089  04.001.640S 7119107  04.001.642S 7117995  04.001.642S 7119125  04.001.644S 7117998  04.001.218S 7327816  04.001.444S 7379241  04.001.620s 7265517  
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		 The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
FDA Determined
Cause 2		 Pending
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 call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-519-5000.
Quantity in Commerce 14
Distribution Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, 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.
510(K) Database 510(K)s with Product Code = JDS and Original Applicant = SYNTHES (USA)
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