Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number Recalled by OrthoPediatrics Corp Due to ShieldLoc implant component of the ACL Reconstruction Systemlots...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OrthoPediatrics Corp directly.
Affected Products
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.
Quantity: 9 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About OrthoPediatrics Corp
OrthoPediatrics Corp has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report