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.
FDA Recall Z-2051-2009 · Posted 2009-09-09
Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeGEI
Date Initiated2009-07-31
Date Terminated2011-02-25
Product Quantity28,074 units
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.