BEUDAMED
    FDA Enforcement Class II Terminated

    PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. 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-0681-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0681-2015
    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, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. 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

    543367 544893 842088 845454 941849 942135 942844 943742 945442 1040419 1041098 1042499 1042929 1043777 1044526 1044527 1045033 1045372 1047071 1141219 1141973 1142134 1142913 1143973 1144935 1145348 1145796 1146957 1147046 1241906 1243270 1244187 1246179 1341468 1341557 1343701 1344283 1344526 1345529 1346236 1346680 1440403 1440910 1442176 1442809 1443395 1443652 646462

    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