BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch intended for use to aspirate bone marrow or autologous blood.

    Recall: Z-0938-2015 · Reported January 14, 2015

    Enforcement

    Recall Number
    Z-0938-2015
    Event ID
    69979
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthovita, Inc., dBA Stryker Orthobiologics.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2015
    Initiation Date
    December 4, 2014
    Classification Date
    January 7, 2015
    Termination Date
    July 28, 2015
    Address
    45 Great Valley Pkwy, N/A, Malvern, PA, 19355-1302, United States

    Description

    Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch intended for use to aspirate bone marrow or autologous blood.

    Reason

    There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.

    Code Info

    all lots of the Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Catalog No.: 2090-0027, 2090-0028, 2090-0029, 2090-0030, 2090-0047

    Distribution

    Worldwide Distribution: US (nationwide) and country of: Canada.

    Quantity

    89770