SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).
FDA device recall Z-1049-03 · posted 2003-07-24 · Terminated
Recall details
- Recalling firm
- Power Medical Interventions
- Reason for recall
- latching mechanism failure
- Action taken
- The recalling firm issued a recall letter dated 6/30/03 to their accounts informing them of the recall and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GAG
- Quantity affected
- 767 units
- Distribution
- The products were shipped to medical facilities and sales representatives nationwide. The products were also shipped to distributors in Belgium, Germany, Ireland, Israel, Italy, Japan, Netherlands, an
- Date initiated
- 2003-06-30
- Date posted
- 2003-07-24
- Date terminated
- 2004-03-16
- 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 SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 (K003277) | Powermed, Inc. | 2000-12-21 |