Events

RECLAIM Distal Reamer Extension 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
    69104
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0038-2015
  • 사례 시작날짜
    2014-09-03
  • 사례 출판 날짜
    2014-10-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129656
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
  • 조치
    On February 25, 2013, DePuy Orthopaedics, Inc. issued a device correction for the specific lots of the RECLAIM Distal Reamer Extension impacted by this recall. The letter stated the reason for the recall and swap out. A subsequent letter outlined a formal swap-out process of the affected reamer extensions as part of the device correction strategy. Newly designed devices are now available. Questions about device swap-out information may be directed to Kim Earle, Recall Coordinator, 574-371-4917; and Surgeon questions may be directed to DePuy's Scientific Information Office at 1-888-554-2482.

Device

RECLAIM Distal Reamer Extension
  • 모델명 / 제조번호(시리얼번호)
    J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586, NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023, 578910, 578913, R578910, R578912, R578913, 582631, and  592125.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the states of ME, MD, PA, MA, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, NC, VA, NY, TN, and IN; and, the countries of Canada, Australia, Austria, Belgium, Czech Republic, United Kingdom, France, Germany, Ireland, Israel, New Zealand, Norway, Poland, Slovenia, South Africa, Switzerland, and Chile.
  • 제품 설명
    RECLAIM Distal Reamer Extension || Non Sterile || REF 2975-00-500 || Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
  • 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