BEUDAMED
    FDA Recall Terminated

    Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.

    Recall: Z-1157-2010 · Initiated February 8, 2010

    Recall

    Recall Number
    Z-1157-2010
    Event Number
    54537
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 8, 2010
    Posted
    March 16, 2010
    Terminated
    February 28, 2013
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.

    Reason

    Fixation device may fail to fire and staple.

    Action

    Covidien notified accounts by "Urgent Medical Device Recall" letters dated 2/8/10. The letter identified the affected product and the reason for recall. Customers are to examine their inventory, and remove and return recalled lots. Customers are to follow the instructions provided in the letter to return the affected product. Questions should be directed to a Covidien Representative. On June 23, 2010, the firm issued a letter to expand the recall to include 5 additional lots.

    Distribution

    Nationwide Distribution

    Quantity

    5,638 units