BEUDAMED
    FDA Enforcement Class II Completed

    3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.

    Recall: Z-2057-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2057-2018
    Event ID
    79978
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 13, 2018
    Initiation Date
    December 21, 2017
    Classification Date
    June 1, 2018
    Address
    5900 Optical Ct, N/A, San Jose, CA, 95138-1400, United States

    Description

    3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.

    Reason

    Inadvertent shipment of expired units.

    Code Info

    Lot No. 14239AG2, UPC 07613327055795. The expiration date marked on the box is August 2018, but it should be August 2016.

    Distribution

    US distribution to Massachusetts only..

    Quantity

    2 boxes (5 units per box)