Events

Recall of Device Recall Procotyl (Rim Lock) Liners

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MicroPort Orthopedics Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75063
  • Event Risk Class
    Class 3
  • Event Number
    Z-0685-2017
  • Event Initiated Date
    2016-06-21
  • Event Date Posted
    2016-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149266
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • 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.
  • Action
    MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or PostMarket@ortho.microport.com. For questions regarding this recall call 901-867-4771.

Device

Device Recall Procotyl (Rim Lock) Liners
  • Model / Serial
    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
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product 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
  • Manufacturer
    MicroPort Orthopedics Inc.

Manufacturer

MicroPort Orthopedics Inc.