Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascular/Thin, Product #ATW35.
FDA device recall Z-0213-04 · posted 2003-12-17 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery
- Reason for recall
- A defective articulation band may result in improper staple formation with possible hematosis.
- Action taken
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 49,395
- Distribution
- The product was shipped to hospitals and distributors located nationwide and worldwide.
- Date initiated
- 2003-11-25
- Date posted
- 2003-12-17
- Date terminated
- 2012-05-09
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS (K020779) | Ethicon Endo-Surgery, Inc. | 2002-06-05 |
| ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER (K961390) | Ethicon Endo-Surgery, Inc. | 1996-06-25 |