BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1671-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1671-2025
    Event ID
    96726
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Straumann USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2025
    Initiation Date
    April 17, 2025
    Classification Date
    April 24, 2025
    Address
    60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States

    Description

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

    Reason

    Incorrect blister labelling.

    Code Info

    Article No. 064.4522S and 064.4523S; UDI (01)07630031775856(11)240613(17)290612(10)GNNA2, (01)07630031775856(11)241115(17)291114(10)JZYZ3, (01)07630031775856(11)241216(17)291215(10)KRJA6, (01)07630031775863(11)240604(17)290603(10)GJXT4, (01)07630031775863(11)241011(17)291010(10)JLLP9, (01)07630031775863(11)241120(17)291119(10)KCKL1, (01)07630031775863(11)241211(17)291210(10)KPRE4, (01)07630031775863(11)250219(17)300218(10)LWZM6; Lot No. (Expiration Date): GNNA2 (6/12/29), JZYZ3 (11/14/29), KRJA6 (12/15/29), GJXT4 (6/3/29), JLLP9 (10/10/29), KCKL1 (11/19/29), KPRE4 (12/10/29), and LWZM6 (2/18/30).

    Distribution

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

    Quantity

    1,786 units