BEUDAMED
    FDA Enforcement Class III Terminated

    Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head

    Recall: Z-0685-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0685-2017
    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

    Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 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 PHA04702 Serial Numbers: PHA04702, 087461467, 089909592, 106368684, 106379196, 106381827, 109949208, 129989153, 0201018636, 0301049040 REF PHA04704 Serial Numbers: 010989155, 027373842, 038461468, 057433172, 077453350, 089924904, 106379197, 106380366, 106381751, 0201018637 REF PHA04706 Serial Numbers: 1414640, 010990534, 017400915, 037415861, 039755749, 047420835, 047424536, 077459275, 087461469, 089906466, 0101034747, 106379879, 106381773, 0301084459, 0401100079, 0501122040, 0801189074 REF PHA04708 Serial Numbers: 010990535, 017400568, 037420836, 047424415, 077455537, 087461470, 089901226, 106380367, 106381752, 0311304891, 0401118999, 0601163086, 0711360334 REF PHA04710 Serial Numbers: 1372615, 1413361, 017400673, 037415862, 037420837, 047423789, 047424535, 077457450, 077460608, 089901146, 098695744, 098695746, 106380368, 106381542, 106381753, 108695745, 109944906, 116380977, 119983782, 129990536, 0201016259, 0301076759, 0311303536, 0311305118, 0401089452, 0401121936, 0501131023, 0801187747, 1291000322 REF PHA04712 Serial Numbers: 029695877, 037414678, 047418090, 057426407, 077457328, 098464129, 099906467, 106373846, 106380571, 116389410, 0201058381, 0301084465, 0311303537, 0401117709, 0601163076, 0801188639 REF PHA04714 Serial Numbers: 1414641, 017400569, 029807399, 037415854, 047423790, 077432883, 077445957, 106368690, 0201025145, 0901196483

    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

    500 units