Recall Z-0459-05 ยท GDW Staple, Implantable
Ethicon Endo-Surgery
Endopath EZ45 Endoscopic Linear Cutter (EZ45G).
| Date | Feb 1, 2005 (initiated Nov 21, 2004) |
| Status | Terminated |
| Reason | The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue. |
| Root cause | Other |
| Action | The firm sent letters, dated 11/21/04, to all consignees. |
| Quantity | 5687 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, Canada, Australia, Brazil, United Arab Emirate, Thailand, Czech Republic, Sweden, Switzerland, Greec |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020779 | PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS Ethicon Endo-Surgery, Inc., Jun 5, 2002 |