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Terminated

ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

FDA Recall Z-2026-2010 · Posted 2010-07-17

Recall StatusTerminated
Product CodeGEY
Date Initiated2009-10-29
Date Terminated2010-08-19
Product Quantity2,373

Reason for Recall

ConMed Linvatec is recalling Advantage, 2-Button Turbo Handpiece Catalog Number D9924. These products may self-activate due to moisture intrusion into the housing body. This issue has been isolated to products manufactured between June 7, 2004 and June 1, 2006.

Firm Action

ConMed Linvatech notified affected customers by letter sent by FedEx next day delivery. Customers were asked to complete a response form and indicated if they have the product or have transferred the product. A Service Request number will be assigned for the returned product. Additional questions are directed to the firm's Customer Service department at 800-535-8536.

Root Cause

Other

Distribution Pattern

Worldwide distribution. Products were distributed domestically throughout the U.S. Also United Arab Emirates, Argentina, Australia, Belgium, Switzerland, Chile, China, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, India, Italy, Japan, Lithuania, Morocco, Netherlands, New Zealand, Singapore, Turkey, South Africa.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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