BEUDAMED
    FDA Recall Terminated

    Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.

    Recall: Z-1755-2015 · Initiated April 16, 2015

    Recall

    Recall Number
    Z-1755-2015
    Event Number
    71171
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    MBF
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 16, 2015
    Posted
    June 11, 2015
    Terminated
    May 16, 2016
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.

    Reason

    Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

    Action

    Biomet sent an Urgent Medical Device Recall Notice letter dated April 29, 2015 to affected customers via Fed-Ex. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete the attached response form and return it along with recalled product to Biomet. For questions callt (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.

    Quantity

    2