BEUDAMED
    FDA Recall Terminated

    Trinity Acetabular System Product Usage - Total Hip Replacement.

    Recall: Z-1526-2016 · Initiated January 29, 2016

    Recall

    Recall Number
    Z-1526-2016
    Event Number
    73205
    Firm
    Corin USA Limited
    FEI Number
    1000131827
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 29, 2016
    Terminated
    December 16, 2019
    Address
    5670 W Cypress St, Ste C, Tampa, FL, 33607-1774

    Description

    Trinity Acetabular System Product Usage - Total Hip Replacement.

    Reason

    Potential for abrasion of the sterile barrier pouches of the new packaging system.

    Action

    Corin sent an Urgent Medical Device Recall letter dated February 3, 2016. The letter identified the affected product, problem and actions to be taken. On January 29, 2016, Eight (8) of 11 distributors were spoken to during a Corin National Sales Meeting informing them of the recall. The 3 remaining distributors were notified by phone calls same date. Also, on February 2, 2016 Corin sent a Recall Letter to their Foreign consignee informating them of the recall of the Trinity Acetabular Shell and the actions to be take by the costumers including the return of the Customer Response Form and Contact information as Corin LTD Compliance Director at +44 (0) 1285 649190 Monday thru Friday 8:30am to 5:00pm UK Time

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.

    Quantity

    629 devices in total