Events

Recall of Device Recall Stryker

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
    62346
  • Event Risk Class
    Class 2
  • Event Number
    Z-1961-2012
  • Event Initiated Date
    2012-06-19
  • Event Date Posted
    2012-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110301
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    The gravity steam, ethylene oxide (eo) and sterrad 100s sterilization methods are being removed from the "instructions for use"; due to the firm's evaluation that identified original validation was not done at worst case conditions.
  • Action
    Stryker Endoscopy sent a Urgent Device Correction letter dated June 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to: 1. Discard any old Instructions for Use for your Arthroscope and Hardware Set Tray. 2. Download the new IFU from the URL link: http://stryker.com/arthrotray . Complete and sign the enclosed acknowledgement of receipt form and fax to (408) 754-8378 or scan in and email to trays@stryker.com.* It is important to send the self addressed confirmation form back to Stryker. Stryker is committed to delivering the highest quality products to its customers. We sincerely apologize for any inconvenience this action may cause. If you have any questions regarding this letter please contact us at 1-800-624-4422 or via email at trays@stryker.com. .

Device

Device Recall Stryker
  • Model / Serial
    All serial/lot numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide)
  • Product Description
    Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA || The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.
  • 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