BEUDAMED
    FDA Enforcement Class II Terminated

    PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    Recall: Z-0594-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0594-2015
    Event ID
    69838
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2014
    Initiation Date
    November 17, 2014
    Classification Date
    December 17, 2014
    Termination Date
    July 17, 2015
    Address
    5900 Optical Ct, N/A, San Jose, CA, 95138-1400, United States

    Description

    PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    Reason

    The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

    Code Info

    Serial/Lot 3282011 06CON06112 817085 0817438/0817442 0817439/0817442 0913442/0913326 0913442/0913523 0913544/0913523 0913581/0913523 0913812/0817492 0913812/0914227 0913812/0915061 0914894/1015779 0915431/1016063 1016560/1016063 1016560/1016826 1016847/1117011 1115970/1117011 1115971/1117011 1116463/1216149 1216408/1216149 1216409/1216149 1216409/1313046 1216409/1313047 1216409/1313048 1216409/1313946 1216720/1313946 913442/913523

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

    Quantity

    180,573 units total