BEUDAMED
    FDA Recall Terminated

    FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays. Intended for transection, resection, and/or creation of anastomoses.

    Recall: Z-1069-2011 · Initiated March 27, 2009

    Recall

    Recall Number
    Z-1069-2011
    Event Number
    57580
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    LRP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 27, 2009
    Posted
    February 15, 2011
    Terminated
    February 15, 2013
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays. Intended for transection, resection, and/or creation of anastomoses.

    Reason

    The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient.

    Action

    Ethicon Endo-Surgery issued "Urgent Expanded Device Recall Event 1981" notification letters dated April 7, 2009, to their customers. They provided a list of all Affected Product Codes of the ETS FLEX45 Articulating Endoscopic Linear Cutters (including the Product Code: ATS45 from the 1st recall) and Affected Flex Tray Codes subject to recall. The notification document reminds the Operating Room and Materials Management customers of the problem which necessitated the previous recall (Z-0361-2011). It goes on to instruct their customers to immediately discontinue use of the affected products. They are to complete and fax back the Business Reply Form, Affected product is to be returned with a copy of the completed Business Reply Form to Stericycle, Replacement product should be received within 30-60 days after return, Customers can contact Stericycle concerning this recall at 1-888-365-4680, reference Event 1981.

    Distribution

    Nationwide Distribution -- USA including the following states, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MO, MS, MT, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, and Puerto Rico.

    Quantity

    135 kits