BEUDAMED
    FDA Recall Open, Classified

    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

    Recall: Z-2010-2023 · Initiated May 30, 2023

    Recall

    Recall Number
    Z-2010-2023
    Event Number
    92459
    Firm
    Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy
    FEI Number
    3008021110
    Product Code
    MBF
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 30, 2023
    Posted
    June 27, 2023

    Description

    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

    Reason

    Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

    Action

    On May 30, 2023 LimaCorporate issued an Urgent: Medical device Recall notification via E-Mail. LimaCorporate asked consignees to take the following actions: 1. Check your stock to locate and quarantine the affected devices. Devices must be sent back to your Lima local reference within 15 days together with a hard copy of the attached Response Form at the following address: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA 2. Fill out, sign and send the attached Response Form via email to your Lima local reference at [email protected] as a confirmation that You have read and acknowledged the content of this FSN. 3. If If needed, please address any inquiry to the email address [email protected].

    Distribution

    US Nationwide distribution in the states of MI, IL, ND, MO, OK.

    Quantity

    13 units