BEUDAMED
    FDA Recall Terminated

    Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.

    Recall: Z-1146-2012 · Initiated November 4, 2010

    Recall

    Recall Number
    Z-1146-2012
    Event Number
    59959
    Firm
    Sybron Dental Specialties
    FEI Number
    2024312
    Product Code
    ELW
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 4, 2010
    Posted
    March 2, 2012
    Terminated
    March 14, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.

    Reason

    Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker.

    Action

    Pentron Clinical sent "Urgent Medical Device Recall" letters dated November 17, 2010 to consignees explaining the above mentioned public reason for recalls and asking them to determine if they have any of the affected products in their in stock. Product that is returned will be replaced at no charge. They also asked that they complete and fax back an enclosed recall return form. Questions can be directed to Customer Service at (800) 551-0283.

    Distribution

    Worldwide Distribution, USA including the states of FL, NY, WA, CA, IL, MA, NC, NJ, AZ, FL, KY, CT, PA, IN, NJ, PA, TN, NV, TX and the countries of Canada and Pakistan.

    Quantity

    176 units