Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of t
FDA device recall Z-2339-2012 · posted 2012-09-10 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- There is potential for the sterility of the product to be compromised.
- Action taken
- Intuitive Surgical sent a "MEDICAL DEVICE CORRECTION" letter dated August 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return via fax to (408) 716-3040. Contact Customer Service at 1-800-876-1310 for questions regarding this recall.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 11,121 Boxes
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon
- Date initiated
- 2012-08-09
- Date posted
- 2012-09-10
- Date terminated
- 2012-12-31
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY (K112263) | Intuitive Surgical, Inc. | 2011-10-07 |