Events

Recall of Device Recall PKG, ATRAUMATIC FORCEPS, SINGLE ACTION

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-0672-2015
  • 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=131740
  • 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, ATRAUMATIC FORCEPS, SINGLE ACTION
  • Model / Serial
    42714 43489 43490 143175 143176 143452 143453 340645 444574 641197 643520 647411 7108579 740242 840911 844136 848107 941058 942653 943254 943440 945124 1040231 1040393 1042255 1042649 1042650 1043453 1046589 1046699 1046906 1141173 1141190 1141384 1143126 1145283 1145682 1145977 1146679 1243100 1243539 1245517 1246171 1340193 1340476 1340586 1341582 1342389 1343704 1344285 1345531 1440912 1441963 1442257 1442810 1443396
  • 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, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. || 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