SurgAssist System Circular Stapler DLU 33mm
FDA device recall Z-0253-04 · posted 2003-12-19 · Terminated
Recall details
- Recalling firm
- Power Medical Interventions
- Reason for recall
- improper staple formation or anvil jam
- Action taken
- On 11/20/03, the recalling firm sent recall notices via overnight carrier to all customers who have been shippped and/or sold the product. The recall notice requested the return of the devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWD
- Quantity affected
- 350 units
- Distribution
- The products were shipped to medical facilities and sales representatives nationwide. The product was also shipped to distributors in the United Kingdom, France, Scotland, Belgium, Germany, Israel, It
- Date initiated
- 2003-11-20
- Date posted
- 2003-12-19
- Date terminated
- 2004-02-10
- Location
- New Hope, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) (K032701) | Power Medical Interventions, Inc. | 2003-09-30 |