BEUDAMED
    FDA Enforcement Class II Ongoing

    Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:

    Recall: Z-0493-2020 · Reported November 27, 2019

    Enforcement

    Recall Number
    Z-0493-2020
    Event ID
    83776
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hager & Meisinger Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2019
    Initiation Date
    November 7, 2018
    Classification Date
    November 19, 2019
    Address
    Ronsdorferstrasse 22, N/A, Dusseldorf, N/A, N/A, Germany

    Description

    Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:

    Reason

    Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging.

    Code Info

    Lot #R23891 UDI: +E0HM26UN2453140099/$$8250523R23891+

    Distribution

    US: NV, PA, FL, SC, IA, NC-

    Quantity

    2500 burs