BEUDAMED
    FDA Recall 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 · Initiated January 30, 2018

    Recall

    Recall Number
    Z-1241-2018
    Event Number
    79353
    FEI Number
    1000116912
    Product Code
    PHX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 30, 2018
    Posted
    March 5, 2018
    Terminated
    May 30, 2023
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    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.

    Action

    The firm disseminated their field safety notices on 01/30/2018 by email. The letter identified the affected product, problem and actions to be taken. The notices requested the trails be returned for replacement.

    Distribution

    US Nationwide Distribution

    Quantity

    387 units