BEUDAMED
    FDA Recall Terminated

    SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.

    Recall: Z-2107-2013 · Initiated February 4, 2013

    Recall

    Recall Number
    Z-2107-2013
    Event Number
    65914
    Firm
    SpineNet
    FEI Number
    3006755626
    Product Code
    GAA
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    February 4, 2013
    Posted
    August 27, 2013
    Terminated
    November 15, 2013
    Address
    1300 Minnesota Ave, Suite 200, Winter Park, FL, 32789-4800

    Description

    SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.

    Reason

    SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.

    Action

    SpineNET sent a "VOLUNTARY PRODUCT RECALL" letter dated 02/04/2013 to Halifax Medical Center. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 407-539-2483 for questions regarding this notice.

    Distribution

    Distributed to one customer in Florida.

    Quantity

    100 units