BEUDAMED
    FDA Enforcement Class II Terminated

    Norian Drillable Inject

    Recall: Z-0617-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0617-2018
    Event ID
    79043
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    August 10, 2017
    Classification Date
    February 15, 2018
    Termination Date
    September 10, 2018
    Address
    1230 Wilson Dr, West Chester, PA, 19380-4231, United States

    Description

    Norian Drillable Inject

    Reason

    The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

    Code Info

    Product Number: 07.704.003S Lot Number: DSD9110

    Distribution

    Nationwide Distribution.

    Quantity

    239 units