Endopath EZ45 Endoscopic Linear Cutter (ET45G).
FDA device recall Z-0461-05 · posted 2005-02-01 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery
- Reason for recall
- The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.
- Action taken
- The firm sent letters, dated 11/21/04, to all consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 1456 devices.
- Distribution
- The product was distributed to hospitals and distributors throughout the United States and to foreign customers located in Korea, China, Republic of Singapore, Argentina, Italy, New Zealand, Austria,
- Date initiated
- 2004-11-21
- Date posted
- 2005-02-01
- Date terminated
- 2008-10-29
- 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 |