Events

Device Recall DePuy Orthopaedics LCS COMPLETE RPS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Orthopaedics, 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
    71085
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1673-2015
  • 사례 시작날짜
    2015-03-04
  • 사례 출판 날짜
    2015-05-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136058
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing - Product Code NJL
  • 원인
    The lcs complete rps knee system has higher rates of revision in australia when the native patella is not resurfaced when compared to other unresurfaced ps implants. if the lcs complete rps knee system is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
  • 조치
    On 3/4/2015, URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System and on 3/19/2015 REVISED URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System (Revised) notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. to 5 p.m. EDT).

Device

Device Recall DePuy Orthopaedics LCS COMPLETE RPS
  • 모델명 / 제조번호(시리얼번호)
    All Lots. Catalog numbers: 129416110 129416112 129416115 129416117 129416120 129416122 129416125 129416210 129416212 129416215 129416217 129416220 129416222 129416225 129416310 129416312 129416315 129416317 129416320 129416322 129416325 129416410 129416412 129416415 129416417 129416420 129416422 129416425 129416510 129416512 129416515 129416517 129416520 129416522 129416525 129416610 129416612 129416615 129416617 129416620 129416622 129416625 129416710 129416712 129416715 129416717 129416720 129416722 129416725 129417110 129417112 129417115 129417117 129417120 129417122 129417125 129417210 129417212 129417215 129417217 129417220 129417222 129417225 129417310 129417312 129417315 129417317 129417320 129417322 129417325 129417410 129417412 129417415 129417417 129417420 129417422 129417425 129417510 129417512 129417515 129417517 129417520 129417522 129417525 129417610 129417612 129417615 129417617 129417620 129417622 129417625 129417710 129417712 129417715 129417717 129417720 129417722 129417725 129495410 129495412 129495415 129495417 129495420 129495510 129495512 129495515 129495517 129495520 129495610 129495612 129495615 129495617 129495620
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.
  • 제품 설명
    LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • 제조사 주소
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA