BEUDAMED
    FDA Enforcement Class II Ongoing

    ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device

    Recall: Z-1169-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1169-2023
    Event ID
    91673
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 8, 2023
    Initiation Date
    February 2, 2023
    Classification Date
    February 24, 2023
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device

    Reason

    Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.

    Code Info

    GTIN 00840420152985, Lot Number 1636048

    Distribution

    US Nationwide distribution in the state of NY.

    Quantity

    10 units