[Recalled] 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications in |
|---|---|
| Brand / manufacturer | OrthoPediatrics Corp |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1536-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 19 April 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
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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