Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to
FDA device recall Z-0763-06 · posted 2006-04-13 · Terminated
Recall details
- Recalling firm
- Medtronic Cardiac Surgery Technologies
- Reason for recall
- Customers stated that the U-Clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the U-Clips.
- Action taken
- A letter and response certificate disseminated to all customers describing problem and recommending return of Spyder devices in inventory. September 1, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- FZP
- Quantity affected
- 3383
- Distribution
- Nationwide (AZ, CA, CT, FL, HI, IA, ID, IL, IN, KS, KY, LA, ,MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, TN, TX, UT, WA, WI, WV). Japan, Belgium, Netherlands, Singapore, and Thailand.
- Date initiated
- 2005-09-01
- Date posted
- 2006-04-13
- Date terminated
- 2007-04-01
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES (K031623) | Coalescent Surgical | 2003-07-03 |
| COALESCENT SURGICAL U-CLIP AND ACCESSORIES (K024366) | Coalescent Surgical | 2003-01-17 |