BEUDAMED
    FDA Enforcement Class II Ongoing

    Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

    Recall: Z-0657-2020 · Reported December 18, 2019

    Enforcement

    Recall Number
    Z-0657-2020
    Event ID
    84191
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2019
    Initiation Date
    October 30, 2019
    Classification Date
    December 6, 2019
    Address
    826 Coal Creek Cir, N/A, Louisville, CO, 80027-9710, United States

    Description

    Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

    Reason

    The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.

    Code Info

    Lot Numbers: 66503918A 066513519A 066529218A 066535518A 66503919 066513519C 66531018 066512319A 066513519E 066531018A 066512319C 66529218 66535518

    Distribution

    US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland,Massachusetts,Michigan,Minnesota,Mississippi,Missouri,Montana,Nebraska,Nevada,New Hampshire,New Jersey,New Mexico,New York,North Carolina,North Dakota,Ohio,Oklahoma,Oregon,Pennsylvania,South Carolina,South Dakota,Tennessee,Texas,Utah,Vermont,Virginia,Washington,West Virginia,Wisconsin,Wyoming, OUS: None: Australia, Austria,Bangladesh,Belgium,Bosnia And Herzegovina,Brazil,Bulgaria,Canada,Canary Islands,China,Colombia,Costa Rica,Croatia,Czech Republic,Denmark,Ecuador,Egypt,Finland,France,Germany,Greece,Hungary,Iceland,India,Indonesia,Ireland,Israel,Italy,Japan,Jordan,Kazakhstan,Kenya,Korea, Republic Of,Latvia,Lebanon,Luxembourg,Malaysia,Martinique,Mexico,Netherlands,New Zealand,Pakistan,Philippines,Poland,Portugal,Puerto Rico,Qatar,Reunion,Romania,Russian Federation,Saudi Arabia,Serbia,Slovakia,Slovenia,South Africa,Spain,Sweden,Switzerland,Thailand,Turkey,United Arab Emirates,United Kingdom

    Quantity

    10,448 disposable biopsy needles