Events

Recall of ASR 300 SIZE 44 ACETABULAR CUPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    51219
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-26
  • 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
    Depuy issued a field safety notice in march 2010 (recall number 53553) after receiving data that demonstrated the asr system had a higher than expected revision rate at three years when used with smaller head sizes. new data now shows a higher than expected revision rate at five years across the entire size range. the manufacturer is therefore issuing a voluntary recall of all asr products.

Device

ASR 300 SIZE 44 ACETABULAR CUPS
  • Model / Serial
    Model Catalog: 999830754 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830752 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830750 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830748 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830746 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 999830744 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 9998-04-348 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-04-146 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-03-944 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-06-370 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-06-168 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-966 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-764 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-562 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-360 (Lot serial: >500 NUMBERS CONTACT MFR); Model Catalog: 9998-05-158 (Lo
  • Product Description
    ASR 300 SPIKED ACETABULAR SHELLS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.