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Terminated

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

FDA Recall Z-1866-2016 · Posted 2016-05-31

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeGEI
Date Initiated2016-03-07
Date Terminated2017-03-31
Product Quantity30,146 Instruments

Reason for Recall

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

Firm Action

Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service.

Root Cause

Other

Distribution Pattern

AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSXomed, Inc. · 1999-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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