BEUDAMED
    FDA Enforcement Class II Terminated

    1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.

    Recall: Z-1250-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1250-2018
    Event ID
    79418
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 4, 2018
    Initiation Date
    November 9, 2017
    Classification Date
    March 28, 2018
    Termination Date
    April 16, 2019
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    Description

    1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.

    Reason

    Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

    Code Info

    1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022 UDI: (01)4546540593108; (01)7613252039259

    Distribution

    Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.

    Quantity

    1244