Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutte

FDA device recall Z-0295-2017 · posted 2016-10-20 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

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.

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.

Root cause

Device Design

Status

Terminated

Product code

GDW

Quantity affected

105

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 Braz

Date initiated

2016-07-15

Date posted

2016-10-20

Date terminated

2017-02-28

Location

Blue Ash, OH

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