BEUDAMED
    FDA Recall Terminated

    Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.

    Recall: Z-0272-2009 · Initiated August 27, 2008

    Recall

    Recall Number
    Z-0272-2009
    Event Number
    49544
    Firm
    Theken Spine LLC
    FEI Number
    3002498892
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 27, 2008
    Posted
    November 18, 2008
    Terminated
    April 13, 2012
    Address
    1800 Triplett Blvd, Akron, OH, 44306-3311

    Description

    Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.

    Reason

    The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010.

    Action

    On 8/27/2008 the firm sent recall notification letters to each of their customers notifying them of the problem with the product. They were requested to return any remaining product back to the recalling firm and to call Customer Service at (866) 942-8698 for an RGA and to arrange shipment. On 8/28/2008 the firm conducted follow up contact each distributor via telephone.

    Distribution

    Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT.

    Quantity

    115 total