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 information: 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 pattern: 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.