BEUDAMED
    FDA Enforcement Class II Terminated

    Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    Recall: Z-1309-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1309-2020
    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

    Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    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)07332747065626(10)73474 (01)07332747065626(10)73369 Catalog# 37081

    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

    260 units