BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.

    Recall: Z-2032-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2032-2014
    Event ID
    68547
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Manufacturing B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    June 12, 2014
    Classification Date
    July 10, 2014
    Termination Date
    June 24, 2015
    Address
    Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715, United States

    Description

    Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.

    Reason

    Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.

    Code Info

    Lot No. 62629432 Lot No. 62628759

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.

    Quantity

    496