BEUDAMED
    FDA Enforcement Class II Terminated

    PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 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-0704-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0704-2015
    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, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 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

    844120 847649 940155 942772 943443 943715 944091 945723 1040113 1041100 1042487 1042719 1042723 1046398 1142140 1143799 1144239 1144648 1146466 1240951 1242121 1242918 1243800 1244525 1244960 1245118 1246168 1246646 1341534 1341555 1342149 1342766 1343299 1343708 1344297 1440434 1440698 1441383 1441957 1442516 UR20257N

    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