BEUDAMED
    FDA Recall Terminated

    Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.

    Recall: Z-2144-2014 · Initiated July 17, 2014

    Recall

    Recall Number
    Z-2144-2014
    Event Number
    68862
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 17, 2014
    Posted
    August 2, 2014
    Terminated
    February 6, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.

    Reason

    Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

    Action

    A recall letter dated 7/22/14 was sent to all customers who purchased the Tapered Screw-Vent Implant to inform them of the recall by Zimmer Dental. The letter informs the customers of the problems identified, risks involved, and the actions to be taken. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, 7-5pm, Mon-Fri. Customers are instructed to complete the customer response form and e-mail a copy to [email protected] or fax to (574) 372-4265.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.

    Quantity

    291 units