CarboFix Orthopedics, Ltd. recalls Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and b…

Recall date

May 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1991-2016

FDA classification

Class II

Brand / firm

CarboFix Orthopedics, Ltd.

Sold / distributed

AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.