Events

Device Recall R3 Forte Ceramic Liners 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
    58324
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2053-2011
  • 사례 시작날짜
    2011-03-11
  • 사례 출판 날짜
    2011-04-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98986
  • 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
    liner - Product Code MRA
  • 원인
    During the manufacturing process for several batches of r3 ceramic liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. this has the potential to result in lower than expected strength for the liners.
  • 조치
    All affected Smith & Nephew Distributors were notified via email and the hospitals were notified by letter delivered by Fed-Ex on 3/11/2011. They were instructed to immediately cease distribution, quarantine affected product for return, if product further distributed, identify customers and immediately notify them of recall. Please contact Mr. David Archer, Group Director, at 701.396.2121, ext. 5373, if you have questions.

Device

Device Recall R3 Forte Ceramic Liners
  • 모델명 / 제조번호(시리얼번호)
    09ET31294, 09FT32646M 09FT32802, 09FT32803, and 09FT33252
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
  • 제품 설명
    R3 TM CERAMIC ACETABULAR LINER, BIOLOX¿ FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 || Usage: Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis or traumatic arthritis
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

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