BEUDAMED
    FDA Enforcement Class III Terminated

    STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

    Recall: Z-1179-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1179-2018
    Event ID
    79297
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 4, 2018
    Initiation Date
    October 16, 2017
    Classification Date
    March 24, 2018
    Termination Date
    April 17, 2019
    Address
    154 Middlesex Tpke, Burlington, MA, 01803-4403, United States

    Description

    STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

    Reason

    A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.

    Code Info

    Lots: 35026, 35579, 36133

    Distribution

    International Distribution to: Germany only.

    Quantity

    55