OrthoPediatrics recalls ACL Reconstruction System ShieldLoc 7mm implant components with incorrect size labels. Products labeled 10-1008-4070 may contain 10-1008-4060, and vice versa. This could lead to improper surgical fixation.
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 ACL Reconstruction System ShieldLoc 7mm implant components that may have the wrong size label. Using these could lead to improper surgical fixation during knee reconstruction procedures.
The implant components may be labeled with the incorrect size (10-1008-4070 vs. 10-1008-4060). This mismatch could lead to improper surgical fixation during knee reconstruction procedures.
Orthopedic surgeons and medical professionals who use this implant during ACL reconstruction procedures. Patients receiving this implant are not directly affected by the recall.
Check for the model number 10-1008-4070 on the packaging. Products labeled as 10-1008-4070 may contain 10-1008-4060, and vice versa.
Look for the model number 10-1008-4070 on the packaging to identify potentially affected items.
The implant components may have the wrong size label (10-1008-4070 vs. 10-1008-4060), which could lead to improper surgical fixation during knee reconstruction procedures.
Check for the model number 10-1008-4070 on the packaging. Products labeled as 10-1008-4070 may contain 10-1008-4060, and vice versa.
The recall does not specify a remedy, so no action is required beyond checking the product label.
We’ve drafted a message you can send OrthoPediatrics to request your refund or repair — edit it as you like.
Subject: Recall Z-2539-2020 — OrthoPediatrics OrthoPediatrics Hello, I own a OrthoPediatrics that is covered by recall Z-2539-2020 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.
