BEUDAMED
    FDA Enforcement Class II Terminated

    Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    Recall: Z-2669-2018 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2669-2018
    Event ID
    79315
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2018
    Initiation Date
    October 24, 2017
    Classification Date
    August 8, 2018
    Termination Date
    May 18, 2023
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    Reason

    Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

    Code Info

    310-0006

    Distribution

    Distribution US Nationwide.

    Quantity

    230