BEUDAMED
    FDA Recall Terminated

    Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.

    Recall: Z-1910-2016 · Initiated May 4, 2016

    Recall

    Recall Number
    Z-1910-2016
    Event Number
    74070
    Firm
    Stryker Corporation
    FEI Number
    2936485
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 4, 2016
    Posted
    June 3, 2016
    Terminated
    June 3, 2016
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.

    Reason

    Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction

    Action

    A recall letter was not sent as all affected devices have been returned. A ship hold was placed on the device on October 16, 2015.

    Distribution

    GA, UT, MD, NJ, MT

    Quantity

    21 units