Recall Z-2051-2009 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Linvatec Corp. dba ConMed Linvatec
REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908. ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting and coagulation device and accessories, intended to remove tissue and control bleeding by use of high-frequency electrical current.
| Date | Sep 9, 2009 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns. |
| Root cause | Device Design |
| Action | ConMed Linvatec is notifying their direct consignees by an Urgent Medical Device Recall letter, requesting that customers check their inventory for the affected products; complete, sign, and return the Reply Form; and return of any affected lot numbers of the product. The product is to be returned to ConMed Linvatec. Questions should be directed to Customer Service at 1-800-237-0169. |
| Quantity | 28,074 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050923 | LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR Conmed Linvatec, May 18, 2005 |