BEUDAMED
    FDA Enforcement Class II Terminated

    PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 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-0725-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0725-2015
    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, RETENTION GRASPER, 33CM, P/N 0250080697 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

    44496 140605 140606 345140 641239 846761 847639 940558 941264 941600 1040627 1040792 1041613 1042525 1043030 1045850 1047039 1141968 1144639 1145068 1146344 1241175 1242199 1242458 1243947 1246162 1340222D 1341522 1341572 1342759 1345289 1345603 141871 1440440 1440691 1441168 1442626 344116 642115

    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