BEUDAMED
    FDA Recall Terminated

    Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).

    Recall: Z-1283-2015 · Initiated February 12, 2015

    Recall

    Recall Number
    Z-1283-2015
    Event Number
    70341
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 12, 2015
    Posted
    March 16, 2015
    Terminated
    July 5, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).

    Reason

    Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.

    Action

    On March 20, 2015, Stryker sent Urgent Medical Device Recall Notifications/Urgent Medical Device Recall Notification Acknowledgement Forms dated March 19, 2015 to all affected customers. The letter identified the product, the related issue and the action to be taken by the customers. Customers were asked to return the attached acknowledgement form confirmed they received and reviewed the notification. Customers with questions were instructed to call 201-831-6365. Stryker sent an Urgent Medical Device Correction letter dated February 11, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the attached acknowledgement form confirming they have received and reviewed the letter. Customers with questions were instructed to call 201-831-6365.

    Distribution

    Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Canada, Hong Kong, Netherlands, Sweden, Switzerland, Spain, France, Italy, UK, India, Australia, Korea, Panama, Polan, Ireland, Kuala Lumpar, New Zealand and South Africa.

    Quantity

    2030 units