BEUDAMED
    FDA Enforcement Class II Terminated

    Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used

    Recall: Z-0174-2015 · Reported November 12, 2014

    Enforcement

    Recall Number
    Z-0174-2015
    Event ID
    69454
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Straumann USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2014
    Initiation Date
    September 24, 2014
    Classification Date
    November 5, 2014
    Termination Date
    June 26, 2017
    Address
    60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States

    Description

    Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used

    Reason

    Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)

    Code Info

    Lot number: GY256

    Distribution

    US Nationwide Distribution

    Quantity

    111 units