BEUDAMED
    FDA Enforcement Class II Terminated

    DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.

    Recall: Z-1300-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1300-2022
    Event ID
    90421
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    July 6, 2022
    Initiation Date
    June 2, 2022
    Classification Date
    June 28, 2022
    Termination Date
    February 12, 2024
    Address
    No. 235 Longhutangjieban Chuangxindadao, Xinbei, Changzhou, N/A, China

    Description

    DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.

    Reason

    One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates

    Code Info

    UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671

    Distribution

    US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, IN, MA, MD, ME, MN, MT, NC, ND, NE, NH, NY, TN, VA, WA, WI.