BEUDAMED
    FDA Recall Terminated

    DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    Recall: Z-2638-2020 · Initiated May 14, 2020

    Recall

    Recall Number
    Z-2638-2020
    Event Number
    85856
    Firm
    Neocis Inc.
    FEI Number
    3012787974
    Product Code
    PLV
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 14, 2020
    Terminated
    July 27, 2021
    Address
    2800 Biscayne Blvd, Ste 600, Miami, FL, 33137-4523

    Description

    DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    Reason

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

    Action

    Customers were notified via UPS overnight mail sent 05/19/2020. Notification also included a site visit from the Neocis Clinical Sales Representative or Neocis Field Clinical Engineer. Customers are asked to stop use of the Gen II Posterior Splints until a trained person from Neocis has inspected their inventory. 100% effectiveness checks are planned.

    Distribution

    US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH

    Quantity

    70 units