BEUDAMED
    FDA Enforcement Class II Terminated

    1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.

    Recall: Z-1254-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1254-2018
    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. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.

    Reason

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

    Code Info

    1. Shelf Life: 12 months; Lot Number: 17277012; 2. Shelf Life: 36 months; Lot Numbers: 17283012, 17299012 UDI: (01)7613252505983; (01)7613252505969

    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

    504