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.
This recall has been terminated (originally issued July 17, 2014).
- Recall Initiated
- June 13, 2014
- Posted
- July 17, 2014
- Terminated
- February 24, 2015
- Recall Number
- Z-2078-2014
- Quantity
- 45
- Firm Location
- Lancaster, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
Star Dental sent a Medical Device Recall letter, dated June 13, 2014 to affected customers. This letter identified the affected product, problem, and actions to be taken. For question call 866-383-4636 extension 4350. The recall was expanded in September 2014 to include additional lot #2251181. A letter, dated September 2014 was sent to customers who were impacted by the recall expansion.