BEUDAMED
    FDA Enforcement Class II Terminated

    PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 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-0774-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0774-2015
    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, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 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

    3252011 745845 845883 846788 9022010 941843 941848 943109 943437 944139 944198 945233 946003 1040123 1041183 1042099 1042469 1042516 1043505 1044519 1045630 1046957 1140647 1142130 1142238 1142926 1143477 1144344 1144640 1145692 1146657 1340921H 1342738 1342742 1345734

    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