8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, I
FDA device recall Z-0660-2007 · posted 2007-03-28 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.
- Action taken
- The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.
- Root cause
- Other
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 8
- Distribution
- Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Ita
- Date initiated
- 2005-03-24
- Date posted
- 2007-03-28
- Date terminated
- 2007-11-28
- 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 BIPOLAR FORCEPS (K012833) | Intuitive Surgical, Inc. | 2001-11-16 |