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U.S. Department of Health and Human Services

Class 2 Device Recall ECHELON 60mm Endoscopic Linear Cutter Reloads Black

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 Class 2 Recall
ECHELON 60mm Endoscopic Linear Cutter Reloads Black
see related information
Date Posted June 11, 2013
Recall Status1 Terminated on February 11, 2014
Recall Number Z-1530-2013
Recall Event ID 65330
Premarket Notification
510(K) Number
K112056 
Product Classification Staple, Implantable - Product Code GDW
Product 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 that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments'®" lock-out feature is designed to prevent a used reload from being refired.
Code Information The following lot numbers and associated expiration dates are affected by this recall: J4AY8Z 5/15/2013, J4C00J 6/15/2013, J4C87R 7/15/2013, J4CC1F 8/15/2013, J4CD2X 8/15/2013, J4CF3D 9/15/2013, J4CJ0E 9/15/2013, J4CJ78 9/15/2013, J4CK2P 9/15/2013, J4CM9X 10/15/2013, J4CR2H 10/15/2013, J4CT5H 11/15/2013, J4CU86 11/15/2013, J4CV1W 11/15/2013, J4CV5H 11/15/2013, K4C149 12/15/2013, K4C17W 12/15/2013, K4C33U 12/15/2013, K4C41C 12/15/2013, K4C600 1/15/2014, K4C64A 1/15/2014, 4C728 1/15/2014, K4C82K 1/15/2014, K4C88F 1/15/2014, K4C94W 1/15/2014, K4CC0L 2/15/2014, CC8L 2/15/2014, K4CD1E 2/15/2014, K4CF1P 2/15/2014, K4CF5D 2/15/2014, K4CG18 3/15/2014, K4CG4J 3/15/2014, K4CG8P 3/15/2014, K4CH44 3/15/2014, K4CK0W 3/15/2014,
Recalling Firm/
Manufacturer
Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati, Ohio 45242-2803
For Additional Information Contact Thomas A. Morris
877-384-4266 Ext. 6
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: 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, keep a copy of this form for your records. Your JJHCS number has been pre-populated on the BRF. Replacement product will be issued for all returned recalled product. 3. All affected product must be returned by August 30, 2013, to receive replacement product. To return affected product, photocopy your completed Business Reply Form, placeit in the box with your product, and affix the pre-printed UPS shipping label to return to Stericycle. Returned ECHELON 60mm Black Reload (ECR60T) will be replaced with corrected ECHELON 60mm Black Reload (ECR60T) as soon as supply becomes available. 4. If you do not have affected product in your inventory, you should still complete and return the Business Reply Form, indicating you have no affected product. 5. Please share this information with all of the appropriate staff at your facility. 6. If you need assistance identifying an alternative product code, please speak directly with your Ethicon Sales Representative. If you need clinical or product support, please contact your local sales representative or call our Customer Support Center, 1-877-ETHICON (877-384-4266 OPTION 6 to speak with a registered nurse). If you need additional shipping labels or a communications package, contact the Stericycle support center at 1-888-943-2397 and reference Event 4706.
Quantity in Commerce 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 Russia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = ETHICON ENDO-SURGERY, LLC
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