BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-1991-2016 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1991-2016
    Event ID
    74229
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CarboFix Orthopedics, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    May 10, 2016
    Classification Date
    June 14, 2016
    Termination Date
    January 27, 2017
    Address
    11 Ha, Hoslim St., Herzliya, N/A, Israel

    Description

    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.

    Reason

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

    Code Info

    Catalog Number PFT912250 - Lot Number QTN90712, QTN02700, QTN61401, QTN02785A, QTN61402, QTN83201B, QTN61402A, QTN43801, QTN43801A, QTN43801B, QTN83201C, QTN04161A

    Distribution

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

    Quantity

    638