Recalls / —
—#144746
Product
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K993655
- Affected lot / code info
- Catalogue No: CEV669E. All batch numbers distributed from January 2011 to February 17, 2016.
Why it was recalled
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Root cause (FDA determination)
Other
Action the firm took
Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI
Timeline
- Recall initiated
- 2016-03-07
- Posted by FDA
- 2016-05-31
- Terminated
- 2017-03-31
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #144746. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.