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U.S. Department of Health and Human Services

Class 3 Device Recall Advantage Drive System

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  Class 3 Device Recall Advantage Drive System see related information
Date Initiated by Firm January 24, 2013
Date Posted March 06, 2013
Recall Status1 Terminated 3 on July 05, 2013
Recall Number Z-0916-2013
Recall Event ID 64367
510(K)Number K050519  
Product Classification Motor, surgical instrument, ac-powered - Product Code GEY
Product D3000 Advantage Drive System, 115v

Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Code Information Model #D3000
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		 The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.
FDA Determined
Cause 2		 Error in labeling
Action Linvatec Corp sent an "URGENT: Medical Device Recall Notification" letter dated January 24, 2013 to its customers after initial phone notifications. The letter describes the affected product, problem and actions to be taken. Customers were instructed to immediate check facility's inventory for the affected product, use the enclosed FedEx air-bill when returning the product, and complete and return to the Recall Reply Form. For questions contact your Customer Service department at 800-535-8536 or fax at 727-319-5701 or email Custserv1@linvatec.com.
Quantity in Commerce 31 units
Distribution Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore
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 = GEY and Original Applicant = LINVATEC CORP.
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