BEUDAMED
    FDA Enforcement Class II Completed

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    Recall: Z-1258-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1258-2018
    Event ID
    79241
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 4, 2018
    Initiation Date
    January 29, 2018
    Classification Date
    March 28, 2018
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    Reason

    It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

    Code Info

    All Serial Numbers

    Distribution

    US Nationwide Distribution

    Quantity

    92 units