BEUDAMED
    FDA Recall Terminated

    Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth

    Recall: Z-0154-2015 · Initiated October 1, 2014

    Recall

    Recall Number
    Z-0154-2015
    Event Number
    69392
    Firm
    Zimmer Dental Inc
    FEI Number
    1038806
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    October 1, 2014
    Posted
    October 30, 2014
    Terminated
    April 28, 2015
    Address
    1900 Aston Ave, Carlsbad, CA, 92008-7308

    Description

    Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth

    Reason

    Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.

    Action

    Customer Notification letters dated 10/6/14 were sent to all customers who purchased the Tapered Screw Vent Implant and the Spline Twist Implant because the incorrect diameter size was printed on the inner vial. The letters informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached Business Reply Form and fax it to (574) 372-4265 or email to [email protected]. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019 from 7am-5pm, Monday-Friday.

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.

    Quantity

    1,044 units