FDA-Device2016-06-22Class II
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.
CarboFix Orthopedics, Ltd.
Hazard
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
Sold states
AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA
Affected count
638
Manufactured in
11 Ha, Hoslim St., Herzliya, Israel
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1991-2016Don't want to check this manually?
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