BEUDAMED
    FDA Enforcement Class II Terminated

    Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

    Recall: Z-1526-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1526-2018
    Event ID
    79751
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    March 12, 2018
    Classification Date
    April 26, 2018
    Termination Date
    May 21, 2020
    Address
    Bohnackerweg 1, N/A, Selzach, N/A, N/A, Switzerland

    Description

    Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

    Reason

    The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling

    Code Info

    Lot # L23745

    Distribution

    USA (nationwide) Distribution

    Quantity

    18