BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker SmartLife Large Aseptic Housing (7126-120-000)

    Recall: Z-1886-2017 · Reported May 3, 2017

    Enforcement

    Recall Number
    Z-1886-2017
    Event ID
    76739
    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
    May 3, 2017
    Initiation Date
    February 28, 2017
    Classification Date
    April 27, 2017
    Termination Date
    January 23, 2023
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    Stryker SmartLife Large Aseptic Housing (7126-120-000)

    Reason

    Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. Using cleaning practices outside of the HIFU could lead to housing separating at the weld.

    Code Info

    Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017

    Distribution

    Domestic: None Foreign: France, Germany

    Quantity

    302