Events

Device Recall ATTUNE" Articulation Surface 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
    71421
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2141-2015
  • 사례 시작날짜
    2015-06-12
  • 사례 출판 날짜
    2015-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137725
  • 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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • 원인
    Potential for the balseal, a small wire spring coil located on the post feature of the attune knee tibial articulation surface instruments used in trialing to become damaged and disassociate (come off). if the balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
  • 조치
    URGENT INFORMATION: MEDICAL DEVICE CORRECTION was issued for all lots of the affected devices. The device correction is to inform US Distributors and Medical Professionals about the issue, how to prevent the issue, and any actions to take. US Distributors will provide Hospitals/User Facilities with the Medical Professional Notice and Acknowledgment Cards. US Distributors will also work with the sales consultants to ensure all consultants complete sales training regarding this issue.

Device

Device Recall ATTUNE" Articulation Surface
  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 254500563, 254500564, 254500565, 254500566, 254500567, and 254500568. GTIN: 10603295133032, 10603295133049, 10603295133056, 10603295133063, 10603295133070, and 10603295133087.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to CANADA , AUSTRALIA, AUSTRIA, BELGIUM, ENGLAND/ UK, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JAPAN, MALAYSIA, NETHERLANDS, NEW ZEALAND, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN & IBERIA, SWEDEN, SWITZERLAND, THAILAND, UAE, CHILE, COLOMBIA, MEXICO, PERU, and PUERTO RICO.
  • 제품 설명
    ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 || INTENDED USE: || The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
  • 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