BEUDAMED
    FDA Recall Terminated

    Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.

    Recall: Z-2605-2021 · Initiated July 28, 2021

    Recall

    Recall Number
    Z-2605-2021
    Event Number
    88589
    Firm
    Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
    FEI Number
    3002806725
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    July 28, 2021
    Terminated
    June 12, 2024

    Description

    Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.

    Reason

    The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

    Action

    On 7/28&29/2021, the firm sent emails entitled "IMPORTANT-containment request FA COUK 2021 013" which notified the consignee they have been identified as receiving one or more of the medical devices listed in the attached Excel file due to them potentially having physical and/or water damage. They were to quarantine the parts until further instructions were issued. On 9/7/2021, Corin USA issued recall letters dated 9/3/2021 via email on 9/7/2021 requesting the devices be quarantined and returned.

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.

    Quantity

    2 units