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FDAMay 10, 2016device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

What to do

FDA enforcement status: Terminated

Brands named

carbofix orthopedicscarbofix

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear