Recall Z-0296-2017
Ethicon Endo-Surgery Inc · initiated July 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
Codes / lots: N91L2N, N91L2P, N91N1J, N91N1K, N91L0T, N91L0U, N91N29, N91N2G, N91R8X, N91R8Y.
Reason for recall
Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
FDA-determined cause: Device Design
Action taken
Ethicon sent an Urgent Medical Device Recall letter dated July 15, 2016, to all affected consignees via UPS next day mail. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were instructed to examine their inventory immediately and quarantine any affected product and return to ENDOPATH. If product subject to the recall was further distributed consignees were instructed to notify the other facility and arrange for return of the affected product. Customer were instructed to complete the Business Reply Form confirming receipt of this letter and fax to Stericycle at 1-888-228-5719 or email to ethicon5182@stericycle.com. Customers with questions were instructed to contact the Ethicon Customer Support Center at 1-877-384-4266. For questions regarding this recall call 513-337-3582.
Details
- Recall number
- Z-0296-2017
- Initiated
- July 15, 2016
- Posted by FDA
- October 20, 2016
- Terminated
- February 28, 2017
- Product code
- GDW – Staple, Implantable
- Quantity
- 213
- Distribution
- Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada.
- Recalling firm
- Ethicon Endo-Surgery Inc, Blue Ash, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0295-2017 Class II | Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex…Quality control identified a component issue where the pinion gear in the device could fail under extreme… | 07/15/2016Terminated |