BEUDAMED
    FDA Enforcement Class II Terminated

    Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

    Recall: Z-2772-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2772-2015
    Event ID
    72054
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthovita, Inc., dBA Stryker Orthobiologics.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2015
    Initiation Date
    August 20, 2015
    Classification Date
    September 16, 2015
    Termination Date
    March 10, 2017
    Address
    45 Great Valley Pkwy, Malvern, PA, 19355-1302, United States

    Description

    Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

    Reason

    Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration

    Code Info

    All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.

    Quantity

    9805