BEUDAMED
    FDA Recall 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 · Initiated December 8, 2015

    Recall

    Recall Number
    Z-0626-2016
    Event Number
    72809
    FEI Number
    1000116912
    Product Code
    PHX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 8, 2015
    Posted
    January 9, 2016
    Terminated
    March 1, 2016
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    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.

    Action

    The recalling firm notified customers of the recall via letter on 12/8/15.

    Distribution

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

    Quantity

    23 units