Recall Z-2538-2020 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
OrthoPediatrics Corp
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
| Date | Jun 5, 2020 |
| Status | Terminated |
| Reason | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package. |
| Root cause | Under Investigation by firm |
| Action | OrthoPediatrics Corporation issued Urgent Medical Device Correction notices dated June 5, 2020 to customers via email. Customers are advised to return affected product to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response form confirming your understanding of these instructions. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality System |
| Quantity | 9 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 |