BEUDAMED
    FDA Enforcement Class II Terminated

    Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

    Recall: Z-1314-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1314-2020
    Event ID
    84450
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nobel Biocare Usa Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 26, 2020
    Initiation Date
    March 14, 2019
    Classification Date
    February 19, 2020
    Termination Date
    February 15, 2024
    Address
    22715 Savi Ranch Pkwy, Yorba Linda, CA, 92887-4609, United States

    Description

    Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

    Reason

    Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

    Code Info

    (01)07332747065480(10)73574 Catalog# 37095

    Distribution

    Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.

    Quantity

    None