BEUDAMED
    FDA Recall Terminated

    Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions made for positioning the laparoscopic cannulas or ports.

    Recall: Z-0622-2009 · Initiated September 25, 2008

    Recall

    Recall Number
    Z-0622-2009
    Event Number
    50489
    Firm
    Genico, Inc., dba Genicon
    FEI Number
    3002590791
    Product Code
    GEA
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    September 25, 2008
    Posted
    December 24, 2008
    Terminated
    January 9, 2009
    Address
    6869 Stapoint Ct, Ste 114, Winter Park, FL, 32792-6603

    Description

    Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions made for positioning the laparoscopic cannulas or ports.

    Reason

    The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar.

    Action

    Consignees were notified with a letter, dated 9/19/2008, by e-mail and fax on 09/25/2008. The letter stated a description of the issue, analysis and reliability data, indications of Device Malfunction, and recommendations. There was also a request for all defective devices to be returned to the distributor or Genicon for replacement. Genicon Customer service was to be contacted at 407-657-4851.

    Distribution

    Worldwide Distribution --- including USA and countries of Africa, United Kingdom, Denmark, Colombia, Belgium, Italy, Finland, Hong Kong, and Switzerland.

    Quantity

    2,965 units (1340 OUS and 1625 US)