BEUDAMED
    FDA Recall Terminated

    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

    Recall: Z-0929-2021 · Initiated October 30, 2020

    Recall

    Recall Number
    Z-0929-2021
    Event Number
    87060
    Firm
    Neocis, Inc.
    FEI Number
    3012787974
    Product Code
    PLV
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 30, 2020
    Terminated
    August 11, 2021
    Address
    530 NW 29th St, Miami, FL, 33127-3917

    Description

    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

    Reason

    The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.

    Action

    The firm initiated the recall by letter on 10/30/2020 via UPS overnight delivery. The letter explains the issue, refers to the original recall and requests that the consignee set aside any affected product. Neocis Field Personnel will inspect the devices and return them to the manufacturing facility.

    Distribution

    OH, FL, CT, MA, AZ PA, NY

    Quantity

    100 units