FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: 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.
- Recall number
- Z-1961-2012
- Recalling firm
- Stryker Endoscopy
- Product
- 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.
- Status
- Terminated
- Initiated
- 2012-06-19
- Posted
- 2012-07-09
- Terminated
- 2012-10-23
- 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.
- Root cause
- Process control
- 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. .
- Quantity
- 6388 units
- Distribution
- Worldwide Distribution--USA (nationwide)
- Lot, serial or model codes
- All serial/lot numbers
- 510(k) numbers
- ["K935237"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28