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OrthoPediatrics Corp recalls 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that o
Recalled September 28, 2016 · FDA recall Z-2843-2016 · OrthoPediatrics
Hazard
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled. · FDA Class II
Units
41
Sold at
Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None
Description
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
Product
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
Manufacturer(s)
OrthoPediatrics Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →