BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS

    Recall: Z-0698-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0698-2024
    Event ID
    93611
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2024
    Initiation Date
    November 28, 2023
    Classification Date
    January 10, 2024
    Address
    200 Medtronic Drive, Lafayette, CO, 80026, United States

    Description

    Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS

    Reason

    Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.

    Code Info

    UDI: 00613994247872/ Serial Numbers: 2023010549, 2023010551, 2023010840, 2023041134, 2023051137, 2023051138, 2023051139, 2023060368, 2023060369

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Oman, Portugal, Spain, Switzerland, United Kingdom.

    Quantity

    4,235 units