BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.

    Recall: Z-0362-2016 · Reported December 9, 2015

    Enforcement

    Recall Number
    Z-0362-2016
    Event ID
    72498
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 9, 2015
    Initiation Date
    September 21, 2015
    Classification Date
    December 2, 2015
    Termination Date
    June 8, 2017
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.

    Reason

    Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).

    Code Info

    Multiple Lot Numbers. Catalog Numbers: 6630-6-105, 6630-6-110, 6630-6-125, 6630-6-130, 6630-6-150, 6630-6-155, 6630-6-170, 6630-6-175, 6630-6-205, 6630-6-210, 6630-6-225, 6630-6-230, 6630-6-250, 6630-6-255, 6630-6-270, 6630-6-275, 6630-6-305, 6630-6-310, 6630-6-325, 6630-6-330, 6630-6-350, 6630-6-355, 6630-6-370, 6630-6-375, 6630-6-405, 6630-6-410, 6630-6-425, 6630-6-430, 6630-6-450, 6630-6-455, 6630-6-470 and 6630-6-475.

    Distribution

    Distributed US (nationwide) and the countries of Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, Netherlands, Poland, Romania, Spain, Sweden and Switzerland.

    Quantity

    2,577 units