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.
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.
조치
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.
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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.