BEUDAMED
    FDA Enforcement Class II Terminated

    AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.

    Recall: Z-0626-2016 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0626-2016
    Event ID
    72809
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2016
    Initiation Date
    December 8, 2015
    Classification Date
    January 9, 2016
    Termination Date
    March 1, 2016
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.

    Reason

    The trial shell mating feature on the broach is undersized.

    Code Info

    178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06

    Distribution

    Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX

    Quantity

    23 units