FDAFDA · Food and drugs·Recall number Z-1534-2013
90 Degree Cannulated Infant Blade Plate 25mm 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 include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
Published June 19, 2013 · Recall initiated: April 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- USA Nationwide Distribution
- Lot
- All lot numbers are affected. Catalog No. 00-1200-1000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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