Events

Device Recall LEGION(TM) HK FEMORAL ASSEMBLY 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, 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
    74271
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2094-2016
  • 사례 시작날짜
    2016-05-26
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147038
  • 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, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • 원인
    The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
  • 조치
    The firm sent an Urgent Product Recall letter dated May 26, 2016 to customers, via email and FedEx Overnight delivery . The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Inspect inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. 2. Complete the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. If you do not have product to return, place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form. 3. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Indicate the RA number on your return shipment.

Device

Device Recall LEGION(TM) HK FEMORAL ASSEMBLY
  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 15KM09184,15LM08835,15LM08837,15LM08839,15LM08840
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
  • 제품 설명
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 || The LEGION Hinge Knee System is indicated for: || 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. || The LEGION Hinge Knee System is for cemented use only.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • 제조사 주소
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA