BEUDAMED
    FDA Recall Completed

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    Recall: Z-0790-2020 · Initiated November 28, 2018

    Recall

    Recall Number
    Z-0790-2020
    Event Number
    84067
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    NDP
    Status
    Completed
    Root Cause
    Process control
    Initiated
    November 28, 2018
    Address
    3050 E Hillcrest Dr, Thousand Oaks, CA, 91362

    Description

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    Reason

    The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.

    Action

    The firm first issued recall letters on 11/28/2018 via FedEx for Part number 6534-09PT and then on 12/28/2018, issued recall letters for Part number 6530-09PT via FedEx. On 2/14/2019, the firm issued another letter to their consignees that added a risk statement regarding the recall of both part numbers (6534-09PT and 6530-09PT).

    Distribution

    Distribution was made to AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, and VA. There was no government/military distribution. Foreign distribution was made to Canada, Armenia, Australia, Denmark, France, Germany, Great Britain, Iceland, Italy, Lithuania, Netherlands, Poland, Spain, Sweden, and Switzerland.

    Quantity

    274 devices