Recall of Device Recall PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69838
  • Event Risk Class
    Class 2
  • Event Number
    Z-0622-2015
  • Event Initiated Date
    2014-11-17
  • Event Date Posted
    2014-12-12
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-07-17
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Endoscope and/or accessories - Product Code KOG
  • 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.
  • Action
    Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.

Device

  • Model / Serial
    141317 142334 246391 341054 341055 04102012E 540683 540685 0541433D 0541434D 6172014 0640767D 0644142D 0647413D 0647616D 0742463D 0743206D 0744706D 0745084D 0746367D 0747892D 08152012E 08426254D 0845326D 0845889D 0846254D 0847431D 0940080D 0940786D 0942136D 0944434D 0944806D 0945985D 1040597D 1040799D 1041469D 1042944D 1043499D 1143128D 1145076D 1145982D 1147040D 1245448 1245519 1245737 1246194 1246197 1341543 1341543D 1341568 1341568D 1344132 1344132D 1344679 13446790 1344679D 1345511 1442519
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. || 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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
  • Source
    USFDA