BEUDAMED
    FDA Recall Terminated

    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

    Recall: Z-2376-2018 · Initiated May 18, 2018

    Recall

    Recall Number
    Z-2376-2018
    Event Number
    80281
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 18, 2018
    Terminated
    July 13, 2020
    Address
    3050 E Hillcrest Dr, Thousand Oaks, CA, 91362

    Description

    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

    Reason

    Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant

    Action

    On May 18, 2018, Implant Direct Sybron Manufacturing LLC issued URGENT MEDICAL DEVICE RECALL notices to their customers. Customers were advised to take the following action: 1. Inspect your inventory for the affected product. 2. Complete and return the Acknowledgement and Recall Return Form within 48 hours for Quarantine product and return products listed. 3. Please return the product and the firm will send you a replacement part. 4. Authorized Implant Direct Sybron Manufacturing distributors, the firm requests that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours. Customers with questions with questions may contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST.

    Distribution

    CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland

    Quantity

    60 units