OrthoPediatrics recalls ACL Reconstruction System ShieldLoc 6mm implant components with incorrect size labels that could lead to improper surgical use. Affected items have model numbers 10-1008-4060 or 10-1008-4070.
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.
OrthoPediatrics is recalling its ACL Reconstruction System ShieldLoc 6mm implant components because some packages contain the wrong model number. This could lead to incorrect surgical use during knee reconstruction procedures.
The implant components are labeled with incorrect model numbers (10-1008-4060 or 10-1008-4070) in the packaging. This could lead to using the wrong size during surgery, potentially causing improper fixation of tendons and ligaments.
Orthopedic surgeons and medical professionals using the ACL Reconstruction System ShieldLoc 6mm implant components for knee surgery are most at risk. Patients receiving this implant during surgery may be affected if the wrong component is used.
Check the model number on the packaging or label. Products labeled as 10-1008-4060 may contain 10-1008-4070, and vice versa. The lot number 214320319A is associated with this recall.
Verify the model number on the packaging to ensure it matches the correct component (10-1008-4060 or 10-1008-4070).
The recall occurs because some packages contain the wrong model number (10-1008-4060 or 10-1008-4070), which could lead to incorrect surgical use during knee reconstruction procedures.
Check the model number on the packaging to ensure it matches the correct component. If you find the wrong model number, contact OrthoPediatrics for guidance.
The official recall notice does not specify a deadline for action.
We’ve drafted a message you can send OrthoPediatrics to request your refund or repair — edit it as you like.
Subject: Recall Z-2538-2020 — OrthoPediatrics OrthoPediatrics Hello, I own a OrthoPediatrics that is covered by recall Z-2538-2020 from OrthoPediatrics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
