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OrthoPediatrics Corp recalls OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is
Recalled July 15, 2020 · FDA recall Z-2539-2020 · OrthoPediatrics
Hazard
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. · FDA Class II
Units
11 units
Sold at
US Nationwide distribution.
Description
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.
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.
Manufacturer(s)
OrthoPediatrics Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →