FDA-Device2017-06-07Class II
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Ethicon Endo-Surgery Inc
Hazard
There is a risk that the pinion gear in the device could fail under extreme use cases.
Sold states
Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
Affected count
792 units
Manufactured in
4545 Creek Rd, Blue Ash, OH, United States
Products
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2174-2017Don't want to check this manually?
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