Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufac
FDA device recall Z-1961-2012 · posted 2012-07-09 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- 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 taken
- 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. .
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 6388 units
- Distribution
- Worldwide Distribution--USA (nationwide)
- Date initiated
- 2012-06-19
- Date posted
- 2012-07-09
- Date terminated
- 2012-10-23
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES (K935237) | Stryker Endoscopy | 1994-03-21 |