BEUDAMED
    FDA Recall Terminated

    2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003

    Recall: Z-1438-2010 · Initiated April 14, 2009

    Recall

    Recall Number
    Z-1438-2010
    Event Number
    55180
    Firm
    Trilliant Surgical LTD
    FEI Number
    3007420745
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 14, 2009
    Posted
    April 26, 2010
    Terminated
    May 3, 2010
    Address
    448 W 19th St, Ste 366, Houston, TX, 77008-3914

    Description

    2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003

    Reason

    Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians.

    Action

    Firm notified sales force by e-mail on 4/14/2009 of the need to recover and reconcile this product . Additional documentation is not available from the firm. Questions may be directed directly to the firm at 800-495-2919.

    Distribution

    WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD

    Quantity

    32 units