BEUDAMED
    FDA Enforcement Class II Terminated

    Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.

    Recall: Z-2529-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2529-2018
    Event ID
    80393
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nobel Biocare Usa Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2018
    Initiation Date
    March 16, 2018
    Classification Date
    July 23, 2018
    Termination Date
    September 11, 2018
    Address
    22715 Savi Ranch Pkwy, N/A, Yorba Linda, CA, 92887-4609, United States

    Description

    Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.

    Reason

    The product label has missing information, such as the lot number and expiration date, as well as other information.

    Code Info

    Lot #1270802

    Distribution

    Worldwide Distribution - US Nationwide in AR, CA, CO, DC, FL, IL, IN, KS, MD, MI, NE, NJ, NY, ND, OH, OK, PA, SC, TX, VA, WA, WI, and WY. Foreign distribution was made to Austria, France, Germany, Hong Kong, Italy, Japan, Lebanon, Mexico, Spain, and Switzerland.

    Quantity

    74 units were distributed to the U.S.