Recall Z-2560-2014 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
OrthoPediatrics Corp
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.
| Date | Aug 29, 2014 (initiated Jul 25, 2014) |
| Status | Terminated |
| Reason | Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. |
| Root cause | 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 | 56 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM OrthoPediatrics Corp., Jun 20, 2013 |