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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 Recall
Synthes Cannulated Distal Femoral Nail (Trauma Nail)
see related information
Date Posted September 18, 2013
Recall Status1 Open
Recall Number Z-2243-2013
Recall Event ID 64406
Premarket Notification
510(K) Number
K970733 
Product Classification Pin, Fixation, Smooth - 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, Pennsylvania 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
PRODUCTION CONTROLS: 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 1 device was distributed in MA.
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 = HTY and Original Applicant = SYNTHES (USA)
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