Events

ASR 300 SIZE 44 ACETABULAR CUPS 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    51219
  • 사례 위험등급
    II
  • 사례 시작날짜
    2010-08-26
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 제품 설명
    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.