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[Recalled] OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures. — The device is a Left 8 hole plate

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductOrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Brand / manufacturerOrthoPediatrics Corp
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2057-2012
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date14 June 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from OrthoPediatrics Corp

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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