FDA-Device2025-04-09Class II
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Ethicon Endo Surgery, LLC
Hazard
Identified curing issues with the silicone during the needles manufacturing process.
Sold states
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
Affected count
2,556 units
Manufactured in
475C - Suite 202, Guaynabo, PR, United States
Products
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1516-2025Don't want to check this manually?
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