BEUDAMED
    FDA Enforcement Class II Terminated

    AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.

    Recall: Z-1241-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1241-2018
    Event ID
    79353
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 4, 2018
    Initiation Date
    January 30, 2018
    Classification Date
    March 28, 2018
    Termination Date
    May 30, 2023
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.

    Reason

    Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.

    Code Info

    Lot Codes: 183312L03, 200006L01, 224643L01

    Distribution

    US Nationwide Distribution

    Quantity

    387 units