BEUDAMED
    FDA Enforcement Class II Terminated

    G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.

    Recall: Z-1838-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1838-2014
    Event ID
    68310
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    May 7, 2014
    Classification Date
    June 19, 2014
    Termination Date
    October 30, 2015
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.

    Reason

    Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

    Code Info

    PN: 110003500. Lots 469610, ZB130701, ZB130702, ZB130703, ZB130901, ZB131001, ZB131002, 881430, ZB131101, ZB140101, and 360877.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.

    Quantity

    1047 total