BEUDAMED
    FDA Recall Terminated

    Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. 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-1351-2012 · Initiated March 12, 2012

    Recall

    Recall Number
    Z-1351-2012
    Event Number
    61440
    Firm
    Straumann USA, LLC
    FEI Number
    1000121052
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 12, 2012
    Posted
    March 30, 2012
    Terminated
    May 31, 2012
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. 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

    Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN

    Action

    Straumann sent a "FIELD CORRECTIVE ACTION NOTICE" dated March 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. Additionally, a Customer Confirmation Form was enclosed for customers to complete and return. Contact the firm at 978-747-2514 for questions regarding this notice.

    Distribution

    Nationwide Distribution.

    Quantity

    346 units