BEUDAMED
    FDA Recall Terminated

    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.

    Recall: Z-2373-2016 · Initiated July 11, 2016

    Recall

    Recall Number
    Z-2373-2016
    Event Number
    74622
    Firm
    Ivoclar Vivadent, Inc.
    FEI Number
    1316092
    Product Code
    EHJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 11, 2016
    Terminated
    September 22, 2017
    Address
    175 Pineview Dr, Amherst, NY, 14228-2231

    Description

    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.

    Reason

    After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.

    Action

    URGENT MEDICAL DEVICE RECALL Letter (dated 7/11/2016) and Response Form were sent to customers on 7/11/2016 via Certified Mail, Return Receipt, Requested. The letter instructs customers to notify their customers of the recall if the product had been distributed and to return the product to Ivoclar Vivadent. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825.

    Distribution

    Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.

    Quantity

    US: 86 units total