BEUDAMED
    FDA Enforcement Class II Terminated

    System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.

    Recall: Z-1066-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1066-2015
    Event ID
    70298
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    January 7, 2015
    Classification Date
    February 9, 2015
    Termination Date
    March 9, 2016
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.

    Reason

    Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are instructed to return recalled product to Stryker.

    Code Info

    Part No. 6126-120-000, Lots 13205, 13209, 13210, 13212

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AR, CA, CO, FL, GA, HI, MD, NC, NY, PA, SC, TX, and VA, and the countries of Australia, Canada, Switzerland, Hong Kong, South Africa, Chile, Korea, Poland, India, Colombia, The Netherlands, and France.

    Quantity

    399