BEUDAMED
    FDA Recall Terminated

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    Recall: Z-0202-2015 · Initiated September 22, 2014

    Recall

    Recall Number
    Z-0202-2015
    Event Number
    69493
    Firm
    Medacta Usa
    FEI Number
    3015500078
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 22, 2014
    Posted
    November 12, 2014
    Terminated
    May 7, 2015
    Address
    1552 W Carroll Ave, Chicago, IL, 60607-1012

    Description

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    Reason

    Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.

    Action

    Medacta sent an URGENT MEDICAL DEVICE letter dated September 22, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its inventory of the device; 2) quarantine and do not use the recalled device; and, 3) return the recalled device upon receipt of a RMA # from the Medacta QA Department. For questions regarding this recall call 805-910-6511.

    Distribution

    Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.

    Quantity

    1 rod (US); 145 rods (global)