—#108915

Product

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 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. Sterile products are individually packed in a transparent tray sealed with Tyvek. Each tray is placed in an individual carton. 3 individual cartons are placed in a corrugated shipper. The ECHELON 60 Endoscopic Linear Cutter Straight, Compact ECHELON 60 Endoscopic Linear Cutter Straight, and the Long ECHELON 60 Endoscopic Linear Cutter Straight are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K051002, K070887
Affected lot / code info: Model # EC60: H44T06, J4A56P, J4A67X, H44T6E, J4A650, J4A762, J4A49A, J4A65N, J4A766, J4A49G, J4A677, J4A76F, J4A567, J4A67D, J4A76L, J4A56F, J4A67H, J4A771; Model # LONG60 lots: H44R8A , H44U3R , H44X17 , J4A55E , J4A64A; Model # SC60: H44R6C, J4A777, J4A58D, J4A77F, J4A58N, J4A78Y, J4A58P.

Why it was recalled

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 (FDA determination)

Vendor change control

Action the firm took

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 were asked to share this information with appropriate staff. If customers should need clinical or product support call 1-800-873-3636, option 6, or contact their local sales representative. For questions regarding this recall call 513-337-7000.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Cincinnati, Ohio 45242-2803

Distribution

Distribution pattern: 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, Japan & Venezuela.

Timeline

Recall initiated: 2012-03-02
Posted by FDA: 2012-05-18
Terminated: 2013-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.