BEUDAMED
    FDA Recall Terminated

    Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. 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 a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

    Recall: Z-2161-2012 · Initiated July 11, 2012

    Recall

    Recall Number
    Z-2161-2012
    Event Number
    62575
    Firm
    Straumann USA, LLC
    FEI Number
    1000121052
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 11, 2012
    Posted
    August 8, 2012
    Terminated
    September 5, 2012
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. 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 a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

    Reason

    Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2

    Action

    Straumann notiifed accounts by telephone on July 10, 2012 and follow-up Field Safety Correction Action letter dated July 11, 2012, via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to discontinue use of the affected product and follow the instruction provided until replacement is received. For questions call 978-747-2514.

    Distribution

    US Nationwide Distribution including the countries of FL, IN, LA, NY and TX.

    Quantity

    14 Distributed in US