Recall Z-2539-2020— OrthoPediatrics Corp
Class II · Terminated
Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2020-06-05, terminated 2021-05-25. FDA's recall record names no specific 510(k) clearance for this event. Product: OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.. 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..
- Recalling firm
- OrthoPediatrics Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-05
- Terminated
- 2021-05-25
- Firm location
- Warsaw, IN, United States
Product description
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.