Events

Recall of LINEAGE/TRANSCEND ARTICULATION SYSTEM - CERAMIC FEMORAL HEADS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MICROPORT ORTHOPEDICS LTD.

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
    78949
  • Event Risk Class
    II
  • Event Initiated Date
    2017-02-10
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    It was found during microport's investigation that the biolox forte 36mm alumina ceramic head was confirmed to measure approximately 2mm shorter than other microport 36mm femoral heads (cobalt chrome and biolox delta ceramic femoral heads). the ultimate hazard would be joint laxity and/or dislocation which could result in revision surgery.

Device

LINEAGE/TRANSCEND ARTICULATION SYSTEM - CERAMIC FEMORAL HEADS
  • Model / Serial
    Model Catalog: 260000011 (Lot serial: > 10 contact manufacturer); Model Catalog: 260000012 (Lot serial: > 10 contact manufacturer); Model Catalog: 260000010 (Lot serial: > 10 contact manufacturer)
  • Product Description
    BIOLOX FORTE 36mm Alumina Ceramic Femoral Heads
  • Manufacturer
    MICROPORT ORTHOPEDICS LTD

Manufacturer

MICROPORT ORTHOPEDICS LTD