FDA-Device2016-06-08Class II

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Integra LifeSciences Corp.
Hazard

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Sold states
AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI
Affected count
30,146 Instruments
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1866-2016

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