BEUDAMED
    FDA Enforcement Class II Terminated

    Trinity Acetabular Shell Product Usage: Total Hip Replacement.

    Recall: Z-1527-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1527-2016
    Event ID
    73205
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Corin USA Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 4, 2016
    Initiation Date
    January 29, 2016
    Classification Date
    April 22, 2016
    Termination Date
    December 16, 2019
    Address
    5670 W Cypress St Ste C, N/A, Tampa, FL, 33607-1774, United States

    Description

    Trinity Acetabular Shell Product Usage: Total Hip Replacement.

    Reason

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

    Code Info

    Cluster Shell 044mm Taper Size 1, Lot Code: 320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298; Cluster Shell 050mm Taper Size 2, Lot Codes: 321954, 322753, 322980; Cluster Shell 050mm Taper Size 3, Lot Codes:

    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