Events

Recall of Device Recall PKG, 3MM PEEK MONOPOLAR HANDLE

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-0773-2015
  • Event Initiated Date
    2014-11-17
  • Event Date Posted
    2014-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131860
  • 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

Device Recall PKG, 3MM PEEK MONOPOLAR HANDLE
  • Model / Serial
    843744 847017 942768 943108 943436 943515 944197 944825 945711 1040927 1042098 1042468 1042513 1042514 1042957 1043819 1045057 1045626 1046584 1140930 1141656 1142239 1144237 1144342 1145343 1146674 1147037 1242641 1243948 1246163H 1340920H 1341894 1341894H 1344199 1344872 1344990 1345272 1345272H 1346215 1346215H 1346684 1440429 1441830
  • 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, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 || 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
    Stryker Endoscopy

Manufacturer

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