Recall Z-1961-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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
| Date | Jul 9, 2012 (initiated Jun 19, 2012) |
| Status | Terminated |
| 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 |
| Quantity | 6388 units |
| Distribution | Worldwide Distribution--USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935237 | STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES Stryker Endoscopy, Mar 21, 1994 |