BEUDAMED
    FDA Enforcement Class II Terminated

    ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.

    Recall: Z-1615-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1615-2014
    Event ID
    68144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2014
    Initiation Date
    April 22, 2014
    Classification Date
    May 13, 2014
    Termination Date
    January 13, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.

    Reason

    This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.

    Code Info

    Catalog Number: 11-210062 Lot Number Identification: 972230

    Distribution

    US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.

    Quantity

    8 devices