Home / Recalls / Medical Devices
ConMed Corporation recalls CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The H
Recalled October 19, 2016 · FDA recall Z-0085-2017 · ConMed
Hazard
CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn. · FDA Class II
Units
Domestic: 1740; Foreign: 4770
Sold at
Worldwide Distribution - US Nationwide in the states of: CA, HI, IL, IN, KS, LA, MA, NC, NM, NY, OH, OK, PA, TN, TX, UT, WA and WI; plus Foreign distribution to Australia, Canada, France, Germany, Italy, Spain, Czech Republic, Lithuania, Netherlands, Poland, Korea,Morocco, Malaysia, Mexico, Taiwan, and South Africa.
Description
CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn.
Product
CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
Manufacturer(s)
ConMed Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →