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U.S. Department of Health and Human Services

Class 2 Device Recall AOS Trochanteric Nail

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  Class 2 Device Recall AOS Trochanteric Nail see related information
Date Initiated by Firm January 14, 2010
Date Posted March 22, 2010
Recall Status1 Terminated 3 on April 26, 2012
Recall Number Z-1191-2010
Recall Event ID 54538
510(K)Number K021008  
Product Classification rod, fixation, intramedullary and accessories - Product Code HSB
Product AOS Trochanteric Nail, 10mm x 20cm x 135¿, Product Part Number: 1042-200.
Code Information Lot Number: 09023.
Recalling Firm/
Manufacturer		 Advanced Orthopaedic Solutions Inc
386 Beech Ave
Torrance CA 90501
For Additional Information Contact
310-533-9966
Manufacturer Reason
for Recall		 The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.
FDA Determined
Cause 2		 Process control
Action The recall was initiated with the firm forwarding a recall notice with attached customer response form on January 14, 2010 to the affected consignees. The recall notice informed the consignees of the reason for recall and gave them three steps to follow to inspect the affected Short Trochanteric Nail products. Consignees were provided with product return instruction for any incorrectly bent products found during their inspection. Customers with questions are instructed to contact the firm at (310) 533-9966.
Quantity in Commerce 27
Distribution Nationwide and Japan
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 = ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
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