BEUDAMED
    FDA Recall Open, Classified

    REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

    Recall: Z-0098-2024 · Initiated August 22, 2023

    Recall

    Recall Number
    Z-0098-2024
    Event Number
    93080
    FEI Number
    1000116912
    Product Code
    PHX
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    August 22, 2023
    Posted
    October 12, 2023
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445

    Description

    REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

    Reason

    Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.

    Action

    On 8/22/23, recall notices were emailed to agents and registration holders who were asked to do the following: Contact Customer Service at 1-800-456-8696 to assist with return and replacement. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. Complete and return the acknowledgement and response form. If you have questions, please email [email protected]

    Distribution

    US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX

    Quantity

    70