Events

Device Recall Triathlon PKR Insert X3 1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics Corp. 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
    50535
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0869-2009
  • 사례 시작날짜
    2008-11-25
  • 사례 출판 날짜
    2009-01-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75714
  • 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
    Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis - Product Code HRY
  • 원인
    Label mix-up: stryker orthopaedics became aware of a lot for lot mix up between triathlon pkr insert x3 #1 lm/rl 8mm, 5630-g-108 lot code nxdmee and triathlon pkr insert x3 #1 rm/ll- 12 mm 5630-g-122 lot code m8jmee.
  • 조치
    Recall notifications entitled "URGENT PRODUCT RECALL" were sent via Federal Express on 11/25/2008 to Stryker branches, hospital risk management, Hospital Chief of Orthopaedics. For further information, please contact Stryker Howmedica Osteonics Corporation by telephone at 201-831-5718.

Device

Device Recall Triathlon PKR Insert X3 1
  • 모델명 / 제조번호(시리얼번호)
    8 mm - LM/RL Catalog number 5630-G-108, Lot code NXDMEE; 12 mm -RM/LL Catalog number 5630-G-122 Lot code M8JMEE.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.
  • 제품 설명
    Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE || Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE || Intended Use: || - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis || - Revision of previous unsuccessful surgical procedures, either involving, or || not involving, previous use of a unicompartmental knee prosthesis || - As an alternative to tibial osteotomy in patients with unicompartmental || osteoarthritis, where bone stock is of poor quality or inadequate for other || reconstructive techniques as indicted by deficiencies of the femoral || condyle/tibia plateau. || These components are intended for implantation with bone cement. || Stryker Orthopaedics; || Howmedica Osteonics Copr. || 325 Corporate Drive || Mahwah, NJ 07430
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA