BEUDAMED
    FDA Enforcement Class II Terminated

    Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    Recall: Z-2699-2018 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2699-2018
    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

    Radial Head Assy Size #4, Rad. 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

    410-0006

    Distribution

    Distribution US Nationwide.

    Quantity

    107