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OrthoPediatrics Corp recalls OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pe
Recalled August 1, 2012 · FDA recall Z-2057-2012 · OrthoPediatrics
Hazard
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. · FDA Class II
Units
15 devices
Sold at
Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Description
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Product
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.
Manufacturer(s)
OrthoPediatrics Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →