BEUDAMED
    FDA Enforcement Class II Terminated

    Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

    Recall: Z-1443-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1443-2018
    Event ID
    79615
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 25, 2018
    Initiation Date
    January 24, 2018
    Classification Date
    April 19, 2018
    Termination Date
    July 30, 2018
    Address
    154 Middlesex Tpke, Burlington, MA, 01803-4403, United States

    Description

    Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

    Reason

    The cutting edge of tissue punches may be potentially damaged with small dents and nicks.

    Code Info

    Lot numbers: 33434, expiration date: 2022-04; 33945, expiration date: 2022-05; 34294, expiration date: 2022-06; and 34987, expiration date: 2022-07.

    Distribution

    Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany

    Quantity

    101