BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1615-2014 · Initiated April 22, 2014

    Recall

    Recall Number
    Z-1615-2014
    Event Number
    68144
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KWI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 22, 2014
    Posted
    May 13, 2014
    Terminated
    January 13, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    Biomet sent an URGENT MEDICAL DEVICE SAFETY ALERT dated April 22, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

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

    Quantity

    8 devices