BEUDAMED
    FDA Enforcement Class II Ongoing

    Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

    Recall: Z-0639-2024 · Reported January 10, 2024

    Enforcement

    Recall Number
    Z-0639-2024
    Event ID
    93650
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer Biomet Spine Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 10, 2024
    Initiation Date
    October 16, 2023
    Classification Date
    January 4, 2024
    Address
    10225 Westmoor Dr, N/A, Westminster, CO, 80021-2702, United States

    Description

    Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

    Reason

    Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.

    Code Info

    UDI-DI: 00889024002159, Lot: W834061

    Distribution

    US Nationwide distribution in the states of MN, NE.

    Quantity

    3