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U.S. Department of Health and Human Services

Class 2 Device Recall LIGHTWAVE SUCTION ABLATOR

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  Class 2 Device Recall LIGHTWAVE SUCTION ABLATOR see related information
Date Initiated by Firm July 31, 2009
Date Posted September 09, 2009
Recall Status1 Terminated 3 on February 25, 2011
Recall Number Z-2051-2009
Recall Event ID 52811
510(K)Number K050923  
Product Classification Electrosurgical Cutting and Coagulation Device and Accessories - Product Code GEI
Product 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.
Code Information All lots manufactured from July 2004 to September 2008: Lot Numbers: 0407121, 0407151, 0407211, 0407271, 0411151, 0411221, 0411291, 0412081, 0412111, 0502161, 0502211, 0504281, 0505021, 0505061, 0505091, 0505101, 0505121, 0505161, 0505171, 0505231, 0506021, 0506131, 0507051, 0508121, 0508221, 0508251, 0509061, 0511021, 0511091, 0511301, 0602231, 0604241, 0606071, 0606191, 0610271, 0611011, 0703121, 0703191, 0704021, 0704091, 0704121, 0705091, 0705231, 0706041, 0706221, 0706271, 0707241, 0708031, 0708131, 0708201, 0711261, 0711301, 0801072, 0801152, 0802132, 0802202, 0803072, 0803112, 0803262, 0803312, 0804171, 0804292, 0805022, 0805061, 0805062, 0806092, 0806262, 0807142, 0807232, 0807292, 0808052, 0808132, 0809032, 0809052, and 0809262.
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Roger Murphy
727-399-5205
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 28,074 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = CONMED LINVATEC
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