Recall Z-2026-2010
Linvatec Corp. dba ConMed Linvatec · initiated October 29, 2009
Product
ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Codes / lots: Lot Number: 00001000 00001023 00001024 00001025 00001026 00001027 00001028 00001029 00001030 00001022 00001031 00001032 00001033 00001034 00001035 00001036 00001037 00001038 00001039 00001040 00001041 00001043 00001042 00001044 00001045 00001046 00001047 00001048 00001050 00001051 00001052 00001049 00001053 00001054 00001055 00001056 00001057 00001058 00001059 00001060 00001062 00001063 00001064 00001065 00001061 00001066 00001067 00001068 00001069 00001070 00001071 00001072 00001073 00001074 00001075 00001076 00001077 00001078 00001079 00001080 00001081 00001082 00001083 00001084 00001085 00001086 00001087 00001088 00001089 00001090 00001091 00001096 00001098 00001099 00001100 00001101 00001102 00001103 00001104 00001105 00001106 00001107 00001108 00001097 00001109 00001110 00001111 00001112 00001114 00001115 00001116 00001117 00001118 00001119 00001120 00001121 00001122 00001113 00001123 00001124 00001125 00001126 00001127 00001129 00001130 00001128 00001131 00001132 00001133 00001134 00001135 00001136 00001137 00001138 00001139 00001140 00001141 00001142 00001143 00001144 00001145 00001146 00001147 00001148 00001149 00001150 00001151 00001152 00001153 00001154 00001155…
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2026-2010
- Initiated
- October 29, 2009
- Posted by FDA
- July 17, 2010
- Terminated
- August 19, 2010
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- 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, Singapore, Turkey, South Africa.
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec, Largo, FL