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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Trauma Nail System

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  Class 2 Device Recall Synthes Trauma Nail System see related information
Date Initiated by Firm November 02, 2012
Date Posted August 26, 2013
Recall Status1 Terminated 3 on September 27, 2016
Recall Number Z-2058-2013
Recall Event ID 65631
510(K)Number K011857  K033071  K033618  K040336  K040762  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Synthes Trauma Nail System. The devices are indication for bone fixation.
Code Information Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Recall Center
877-650-8664
Manufacturer Reason
for Recall		 Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
FDA Determined
Cause 2		 Packaging change control
Action The firm initiated their recall of this product on November 2, 2012 by sending an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter to all consignees. The letter explained the problem and gave instructions for consignees to examine their inventory and urged consignees to return the identified devices. The letter stated If returning the product would adversely impact their ability to provide necessary medical care to patients, they should re-sterilize the product per Pre-Vacuum Sterilization instructions contained in the Instruction for Use.
Quantity in Commerce 1,011,783
Distribution Nationwide distribution.
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 = HSB and Original Applicant = SYNTHES (USA)
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