Date Initiated by Firm |
July 25, 2014 |
Date Posted |
August 29, 2014 |
Recall Status1 |
Terminated 3 on May 19, 2015 |
Recall Number |
Z-2560-2014 |
Recall Event ID |
69050 |
510(K)Number |
K130217
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Product Classification |
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
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Product |
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm
Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
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Code Information |
Part #: Lot Code: 01-1008-0040 132762 01-1008-0041 F132764, F132763 01-1008-0042 F132763, F132764 01-1008-0043 F132765, F132766 01-1008-0044 F132766, F132765 01-1008-0045 F132768 01-1008-0046 F132769 01-1008-0047 F132770 |
Recalling Firm/ Manufacturer |
OrthoPediatrics Corp 2850 Frontier Dr Warsaw IN 46582-7001
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For Additional Information Contact |
Greg Teghtmeyer 574-268-6379
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Manufacturer Reason for Recall |
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
OrthoPediatrics sent a Notification letter dated July 25, 2014 to all affected customers. The letter Identified the affected product, problem and actions to be taken. The letter informed customers to take immediate possession of all affected product within their control and at any of their health care facilities and immediately return the recalled device(s) to OrthoPediatrics Corp. This notice and the attached Reply Form should be forwarded if the affected product was further distributed. . |
Quantity in Commerce |
56 units |
Distribution |
US Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MBI and Original Applicant = ORTHOPEDIATRICS, CORP.
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