FDAFDA · Alimentos y medicamentos·N.º oficial Z-2078-2014
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
Publicado el 23 de julio de 2014 · Inicio del retiro: 13 de junio de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Dental EZ Group Star Dental Division
- Distribuidor
- US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.
- Lote
- Lot # 2239818, Model - Titan-T 5K Motor, Catalog Number - 263940, with serial numbers: AC00001M7, AC00002M7, AC00003M7, AC00004M7, AC00005M7, AC00006M7, AC00007M7, AC00008M7, AC00009M7, AC00010M7, AC00011M7, AC00012M7 , AC00013M7, AC00014M7, AC00015M7, AC00016M7, AC00017M7, AC00018M7, AC00019M7, AC00020M7, AC00021M7, AC00022M7, AC00023M7, AC00024M7, AC00025M7 The recall was expanded in September 2014 to include additional lot #2251181 (catalog #263940) with serial numbers: AC00026M7, AC00027M7, AC00028M7, AC00029M7 , AC00030M7, AC00031M7, AC00032M7, AC00033M7, AC00034M7, AC00035M7 , AC00036M7, AC00037M7, AC00038M7, AC00039M7, AC00040M7, AC00041M7 , AC00042M7, AC00043M7, AC00044M7, AC00045M7.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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