BEUDAMED
    FDA Enforcement Class II Terminated

    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland

    Recall: Z-2363-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2363-2015
    Event ID
    71445
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 19, 2015
    Initiation Date
    May 12, 2015
    Classification Date
    August 10, 2015
    Termination Date
    October 5, 2016
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland

    Reason

    A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.

    Code Info

    Catalog #5901-S-4818, Lot MAC7C14.

    Distribution

    US Nationwide

    Quantity

    21 units