—#144745

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's: CEV649B5, CEV649BGP, CEV649GP, CEV8649B5, CEV8649BGP, CEV646B5, CEV647B5, CEV648B5, CEV649-5B, CEV649-5N, CEV8646B5, CEV8647B5, CEV8648B5, CEV1019-5B, CEV10195C, CEV10195D, CEV1019-5N, CEV10195NA, CEV10195R, CEV1039-5-B, CEV10395D, CEV1039-5N, CEV3911, CEV3931, CEV3941, CEV3951, CEV3961, CEV3981, CEV3991, CEV8991, CEV104M, CEV114M, CEV211, CEV220, CEV391B, CEV394B, CEV395B, CEV399B, CEV899, CEV405, CEV406, CEV407, CEV460, CEV470, CEV470-1, CEV511M, CEV514M, CEV515M, MCLP20, MCLP25, MCLP30, MCLP40, CEV8649GP, DEV9649B5, CEV9649BGP, CEV9649GP, CEV8649-5-B, CEV8649-5N, CEV9646B5, CEV9647B5, CEV9648B5, CEV9649-5-B, CEV9649-5N, CEV10395R, CEV1039G5, CEV618-5N, CEV6185R, CEV638-5N, CEV6385R, CEV720BR, CEV720R, CEV7285R, CEV605-5, CEV8911, CEV8931, CEV8941, CEV8951, CEV8961, CEV8981, CEV520M, CEV525M, CEV531-3, CEV815M, CEV891M, CEV894M, CEV895M, CEV995M, CEV996M, CEV997M, CEV998M, CM107, CM110, CM111, CM111R, CM112, CM113, CM115 and CM120. 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 #144745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.