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.
FDA Recall Z-2078-2014 · Posted 2014-07-17
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Recalling FirmDental EZ Group Star Dental Division
Recall StatusTerminated
Product CodeEFA
Date Initiated2014-06-13
Date Terminated2015-02-24
Product Quantity45
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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