Recall Z-0579-2014 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
OrthoPediatrics Corp
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.
| Date | Dec 26, 2013 (initiated Nov 7, 2013) |
| Status | Terminated |
| Reason | Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size. |
| Root cause | 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 | 40 |
| Distribution | Nationwide Distribution including the states of CA, KY, OH, RI, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM OrthoPediatrics Corp., Jun 20, 2013 |