Recall Z-1627-2012 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter - Straight are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. ECHELON 60 instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The i
| Date | May 18, 2012 (initiated Mar 2, 2012) |
| Status | Terminated |
| Reason | There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this issue, the device does not open either with the anvil release button or with the manual firing release lever. |
| Root cause | Vendor change control |
| Action | Ethicon Endo-Surgery sent an Urgent Device Recall letter dated March 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have the affected product and to remove the affected product. Fill out the Business Reply Form and fax it to 1-513-337-4138 within 3 business days, even if they do not have the affected product in their inventory. Ethicon will automatically replace any affected product returned by June 29, 2012. Customers wer |
| Quantity | 3120 |
| Distribution | Worldwide Distribution - USA including AL, AR, CA, CO, FL, IA, IL, KS, LA, MD, MO, MS, NC, NM, NY, OH, SC, TX & VA; and the countries of Argentina, Ecuador, Mexico, Australia, Egypt, Singapore, Belgium, Greece, Slovenia, Brazil, India, South Africa, China, Israel, United Arab Emirates, Colombia, Jap |
| FDA record | Open on fda.gov |