OrthoPediatrics ACL Reconstruction SystemRecalls & reported problems across all models
Orthopediatrics Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of OrthoPediatrics ACL Reconstruction System by Orthopediatrics Corp. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
2 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
OrthoPediatrics ACL Reconstruction System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 5, 2020Terminated
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.
Z-2539-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 5, 2020Terminated
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.
Z-2538-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
OrthoPediatrics ACL Reconstruction System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OrthoPediatrics ACL Reconstruction System 10-1008-4060FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 recall0 reports
- OrthoPediatrics ACL Reconstruction System 10-1008-4070FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 recall0 reports
Other Orthopediatrics Corp. products
All Orthopediatrics Corp. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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