BEUDAMED
    FDA Enforcement Class III Terminated

    Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head

    Recall: Z-0686-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0686-2017
    Event ID
    75063
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroPort Orthopedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2016
    Initiation Date
    June 21, 2016
    Classification Date
    December 1, 2016
    Termination Date
    July 1, 2017
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501, United States

    Description

    Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head

    Reason

    Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

    Code Info

    REF 36693646 Serial Numbers: 09230967, 09229086, 10230508 REF 36693848 Serial Numbers: 08228745, 10230509, 11235075 REF 36694050 Serial Numbers: 09229091, 09230501 REF 36694252 Serial Numbers: 09229131, 10230510 REF 36694454 Serial Numbers: LLALMB161A, 09230503 REF 36694656 Serial Numbers: 09230505, 11230847 REF 36694858 Serial Numbers: 09229167, 10230511 REF 36695060 Serial Numbers: 09229169, 09230506 REF 36695262 Serial Numbers: 09230507, 09229170 REF 36695464 Serial Numbers: 08228747, 10230512

    Distribution

    Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    22 units