BEUDAMED
    FDA Enforcement Class II Terminated

    CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.

    Recall: Z-1635-2016 · Reported May 18, 2016

    Enforcement

    Recall Number
    Z-1635-2016
    Event ID
    73846
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2016
    Initiation Date
    April 12, 2016
    Classification Date
    May 10, 2016
    Termination Date
    December 12, 2016
    Address
    5900 Optical Ct, N/A, San Jose, CA, 95138-1400, United States

    Description

    CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.

    Reason

    Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deployment of the anchor.

    Code Info

    Model number: CAT02643; Serial numbers: 15122202, 16011301,16020802

    Distribution

    Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.

    Quantity

    3100 total devices, both models