BEUDAMED
    FDA Recall Terminated

    CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; 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-1634-2016 · Initiated April 12, 2016

    Recall

    Recall Number
    Z-1634-2016
    Event Number
    73846
    Firm
    Stryker Corporation
    FEI Number
    2936485
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 12, 2016
    Terminated
    December 12, 2016
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; 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 s of an internal wire breaking upon deployment of the anchor.

    Action

    Urgent Medical Device Recalls letters were sent on April 12, 2016 to US customers by certified mail. Stryker International distribution sites will be notified by e-mail. Letters describe the reason for recall with the affected part and lot numbers. Any recalled product should be segregated and returned to Stryker.

    Distribution

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

    Quantity

    3100 total device, both model numbers.