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U.S. Department of Health and Human Services

Class 2 Device Recall ACL Reconstruction System Installation tools

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 Class 2 Recall
ACL Reconstruction System Installation tools
see related information
Date Posted December 26, 2013
Recall Status1 Terminated on May 09, 2014
Recall Number Z-0579-2014
Recall Event ID 67003
Premarket Notification
510(K) Number
K130217 
Product Classification Fastener, Fixation, Nondegradable, Soft Tissue - Product Code MBI
Product OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.
Code Information Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770
Recalling Firm/
Manufacturer
OrthoPediatrics Corp
2850 Frontier Dr
Warsaw, Indiana 46582-7001
For Additional Information Contact Greg Teghtmeyer
574-268-6379
Manufacturer Reason
for Recall
Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action November 7, 2013 all consignees were notified of the Urgent Device recall via telephone calls and E-mail messages describing the product and reason for the recall,. The notice included directions to identify and quarantine the recalled devices returning product to OrthoPediatrics with completed return form to OrthoPediatrics via mail, email or courier service, or by photographing with a smart phone and emailing to logistics@orthopediatrics.com or by answering the recall specific questionsin an email to mfox@orthopediatrics.com.
Quantity in Commerce 40
Distribution Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
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 = MBI and Original Applicant = ORTHOPEDIATRICS, CORP.
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