BEUDAMED
    FDA Recall Open, Classified

    WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

    Recall: Z-1671-2025 · Initiated April 17, 2025

    Recall

    Recall Number
    Z-1671-2025
    Event Number
    96726
    Firm
    Straumann USA LLC
    FEI Number
    1000121052
    Product Code
    NHA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 17, 2025
    Posted
    April 24, 2025
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

    Reason

    Incorrect blister labelling.

    Action

    An "Urgent Field Safety Action" notification dated 4/17/2025 was mailed to consignees. The notification instructs consignees to immediately check inventory for affected devices and to quarantine any units identified as in stock. Any recalled devices identified are to be returned to Straumann USA LLC to the attention of Jennifer Jackson for credit or replacement. For affected devices that have been implanted, consignees are being instructed to evaluate the compatibility based on the provided instructions. Consignees are asked to return the provided Customer Confirmation Form using the UPS label included in the notification.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.

    Quantity

    1,786 units