Recall Z-1530-2013 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line
| Date | Jun 11, 2013 (initiated May 13, 2013) |
| Status | Terminated |
| Reason | Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence. |
| Root cause | Device Design |
| Action | Ethicon sent a Urgent: Medical Device Recall letter dated May 29, 2013, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were instructed 1.To examine your inventory immediately to determine if you have affected product manufactured by Ethicon and remove the affected product(s). See Attachment A for assistance in identifying affected product. 2. Complete the Business Reply Form (BRF) Attachment C and fax or email it to Stericycle at 1-888-943-4190. Please reference Event 4706. If you have product to be returned, k |
| Quantity | 57,540 Units |
| Distribution | Worldwide Distribution - US Nationwide all fifty states and including the countries of Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puerto Rico, Turkey, Columbia, Kuwait, Qatar, United Arab Emirates, Egypt, Lebanon and |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112056 | ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL Ethicon Endo-Surgery, LLC, Dec 19, 2011 |