Recall Z-0085-2017 ยท JOS Electrode, Electrosurgical
ConMed Corporation
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.
| Date | Aug 29, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process change control |
| Action | Conmed sent an URGENT DEVICE RECALL letter dated August 31, 2016 and Business Reply Form were sent to the domestic consignees on August 29, 2016 via USPS First Class Mail. The letter identified the affected product, problem and actions to be taken. For questions or requests contact the Field Action Support Team at 1-800-535-8536, fax to 315-624-3225, or email largheatwv@conmed.com. |
| Quantity | Domestic: 1740; Foreign: 4770 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991830 | CAPSULAR SHRINKAGE ELECTRODE Linvatec Corp., Aug 20, 1999 |