Events

Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM 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
    50901
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1369-2009
  • 사례 시작날짜
    2009-01-06
  • 사례 출판 날짜
    2009-07-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78788
  • 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, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • 원인
    Product deviation : specific lots of sprayed ha hip stems did not meet stryker's internal material specification for tensile bond strength and crystallinity.
  • 조치
    An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.

Device

Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6021-0740 ACCOLADE PLUS TMZF HIP STEM #7 25138602.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; || V40 taper || Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • 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