BEUDAMED
    FDA Enforcement Class II Terminated

    Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 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.

    Recall: Z-0117-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0117-2015
    Event ID
    69379
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Straumann USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2014
    Initiation Date
    September 19, 2014
    Classification Date
    October 23, 2014
    Termination Date
    March 13, 2015
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008, United States

    Description

    Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 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.

    Reason

    Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

    Code Info

    Lot number: GY030 Exp. 2019-04

    Distribution

    US Distribution in states of: FL and MA.

    Quantity

    6 units