BEUDAMED
    FDA Recall 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 · Initiated June 2, 2022

    Recall

    Recall Number
    Z-1300-2022
    Event Number
    90421
    Firm
    CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. No. 235 Longhutangjieban Chuangxindadao Xinbei Changzhou China
    FEI Number
    3007923096
    Product Code
    LXT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 2, 2022
    Posted
    June 28, 2022
    Terminated
    February 12, 2024

    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

    Action

    On June 2, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to return all affected product. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].

    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.