Z-2174-2017 Class II Terminated

Recalled by Ethicon Endo-Surgery Inc — Blue Ash, OH

Recall Details

Product Type
Devices
Report Date
June 7, 2017
Initiation Date
March 31, 2017
Termination Date
May 3, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
792 units

Product Description

Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

Reason for Recall

There is a risk that the pinion gear in the device could fail under extreme use cases.

Distribution Pattern

Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.

Code Information

N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G