The Recall Desk

FDA (Devices) recall action 65091

OrthoPediatrics Corp recalled 3 products on 2013-06-19

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2013-06-19
Critical
0
Units
390

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 130 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    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. Spe
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 30mm 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. Spe
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    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. Spe
    Category
    Distribution
    0 states