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CarboFix Orthopedics, Ltd. recalls Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and be
Recalled June 22, 2016 · FDA recall Z-1991-2016 · CarboFix Orthopedics
Hazard
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility. · FDA Class II
Units
638
Sold at
AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA
Description
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
Product
Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Manufacturer(s)
CarboFix Orthopedics, Ltd.
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →