BEUDAMED
    FDA Recall 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 · Initiated September 24, 2014

    Recall

    Recall Number
    Z-0174-2015
    Event Number
    69454
    Firm
    Straumann USA, LLC
    FEI Number
    1000121052
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 24, 2014
    Posted
    November 6, 2014
    Terminated
    June 26, 2017
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    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)

    Action

    Straumann USA sent a Field Corrective Action Notice letter dated September 24, 2014 and delivered via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Straumann is requesting the return of unused implants. Returns and Customer Confirmation form is to be returned. Contact firm 781-747- 2514.

    Distribution

    US Nationwide Distribution

    Quantity

    111 units