BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures

    Recall: Z-0781-2020 · Reported January 15, 2020

    Enforcement

    Recall Number
    Z-0781-2020
    Event ID
    84451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2020
    Initiation Date
    November 21, 2019
    Classification Date
    January 7, 2020
    Termination Date
    November 13, 2020
    Address
    Bohnackerweg 1, N/A, Selzach, N/A, N/A, Switzerland

    Description

    Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures

    Reason

    Pin To Rod Coupling could not clamp the pin and rod as intended

    Code Info

    Lot Number: D30875 UDI : (01)07613327089158(10)D30875

    Distribution

    Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China.

    Quantity

    N/A