BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2078-2014 · Initiated June 13, 2014

    Recall

    Recall Number
    Z-2078-2014
    Event Number
    68609
    Firm
    Dental EZ Group Star Dental Division
    FEI Number
    2520265
    Product Code
    EFA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 13, 2014
    Posted
    July 17, 2014
    Terminated
    February 24, 2015
    Address
    1816 Colonial Village Ln, Lancaster, PA, 17601-5891

    Description

    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.

    Reason

    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.

    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.

    Distribution

    US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.

    Quantity

    45