FDAFDA · Food and drugs·Recall number 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.
Published July 23, 2014 · Recall initiated: June 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dental EZ Group Star Dental Division
- Distributor
- US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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