Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01
FDA device recall Z-0723-05 · posted 2005-04-22 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Blades on the scissor may break and separate from the main unit as a result of corrosion damage.
- Action taken
- The firm has sent notification letters to its consignees on 03/09/2005. Consignees are requested to return the feedback form provided by Intuitive Surgical, via Federal Express.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRW
- Quantity affected
- 278 units have been distributed.
- Distribution
- The product was distributed to 84 medical facilities, located throughout the US and Switzerland, Belgium, Germany, Australia, Turkey and France.
- Date initiated
- 2005-03-09
- Date posted
- 2005-04-22
- Date terminated
- 2005-05-13
- 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 |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 (K021036) | Intuitive Surgical, Inc. | 2002-06-26 |