|
Class 2 Device Recall ACL Reconstruction System Installation tools |
|
Date Initiated by Firm |
November 07, 2013 |
Date Posted |
December 26, 2013 |
Recall Status1 |
Terminated 3 on May 09, 2014 |
Recall Number |
Z-0579-2014 |
Recall Event ID |
67003 |
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 IN 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 |
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 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 = MBI and Original Applicant = ORTHOPEDIATRICS, CORP.
|
|
|
|