Recall Z-2026-2010 ยท GEY Motor, Surgical Instrument, Ac-Powered
Linvatec Corp. dba ConMed Linvatec
ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
| Date | Jul 17, 2010 (initiated Oct 29, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 2,373 |
| Distribution | 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, Sin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.