BEUDAMED
    FDA Recall Open, Classified

    Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

    Recall: Z-1994-2026 · Initiated March 27, 2026

    Recall

    Recall Number
    Z-1994-2026
    Event Number
    98681
    Firm
    Straumann USA LLC
    FEI Number
    1000121052
    Product Code
    NHA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 27, 2026
    Posted
    April 29, 2026
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

    Reason

    Includes an incorrect screw seat interface.

    Action

    Straumann USA notified consignees on about 03/27/2026 via telephone call, mailed letter, or email. Consignees were instructed to examine inventory for affected product, cease use and quarantine any affected units on hand, arrange for the return of all affected units and complete and return the provided Customer Confirmation Form. Consignees were also instructed to no contact Straumann contact Jennifer Jackson to organize a remake of the units, if any were used. Once the new restoration is available, schedule the patient to replace the restoration.

    Distribution

    US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.

    Quantity

    5 units