Reported Oct 19, 2016 · Terminated
CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The…
ConMed Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConMed Corporation · 525 French Rd · Utica, NY · 13502-5945
Is this the product you have?
- CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE
- Rx Only Product UsageThe HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures
- Lot codes and dates
- All lots codes manufactured
- from 09/01/2011 through 11/17/2015
76 of 76 codes
267221301001309889318652319649325019354759334627336041341704343927349952384294354768365239369773374480378521406137385695388538392382394178396542436808413702456341423877427704433503478513451923488101464062468012471297511327482366522335494840499981505321544240515060551152527734531802536700581072550988590037557461570449574167611804588892621304597982598682605515
- Amount recalled
- Domestic: 1740; Foreign: 4770
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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