BEUDAMED
    FDA Recall Terminated

    Norian Drillable Inject

    Recall: Z-0617-2018 · Initiated August 10, 2017

    Recall

    Recall Number
    Z-0617-2018
    Event Number
    79043
    Firm
    Synthes USA
    FEI Number
    3008812560
    Product Code
    OIS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 10, 2017
    Terminated
    September 10, 2018
    Address
    1230 Wilson Dr, West Chester, PA, 19380-4231

    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.

    Action

    On August 15, 2017 an Urgent Medical Device Recall notice, titled "895204 NORIAN DRILLABLE INJECT" was issued to customers instructing them to review inventory and quarantine all affected product subject to the recall. For questions. concerns or to obtain a return authorization Call 1-800-479-6329. Returned product will be credited.

    Distribution

    Nationwide Distribution.

    Quantity

    239 units