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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Cannulated Distal Femoral Nail (Trauma Nail)

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  Class 2 Device Recall Synthes Cannulated Distal Femoral Nail (Trauma Nail) see related information
Date Initiated by Firm April 18, 2013
Date Posted September 18, 2013
Recall Status1 Terminated 3 on March 30, 2015
Recall Number Z-2243-2013
Recall Event ID 64406
510(K)Number K970733  
Product Classification Fixation Pin - Product Code HTY
Product Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
Code Information Part Number 450.851S, Lot Number 7065061
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Synthes Customer Service
610-719-5000
Manufacturer Reason
for Recall		 Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
FDA Determined
Cause 2		 Packaging process control
Action A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested.
Quantity in Commerce 1
Distribution US distribution to MA.
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 = HTY and Original Applicant = SYNTHES (USA)
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