FDA-Device2016-12-07Class II
FMsealer Open Shears. Model FM3001
Domain Surgical, Inc.
Hazard
Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
Sold states
Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
Affected count
70 units US; 175 units OUS
Manufactured in
1370 S 2100 E, Salt Lake City, UT, United States
Products
FMsealer Open Shears. Model FM3001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0690-2017Don't want to check this manually?
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