Events

Device Recall Triathlon AR 4:1 Cutting Blocks 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
    52641
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1916-2009
  • 사례 시작날짜
    2007-02-12
  • 사례 출판 날짜
    2009-08-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-10-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83571
  • 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
    orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Triathlon cutting blocks did not assemble to the triathlon impactor/extractor handle.
  • 조치
    Important Product Correction letters were sent to all branches/agencies on February 12, 2008 by Federal Express. The letter asked consignees to examine their inventory and hospital locations to identify the affected product. Customers were asked to perform a functional inspection by assembling the Triathlon Impactor/Extractor Handle to all of their MIS Cutting Blocks. If the cutting block does not assemble, customers are to list the affected lot codes on the Attached Product Accountability Form and fax a copy to (201) 831-6069. The letter states that product should not be returned until further instructions are received. Questions should be directed to (201) 831-5825.

Device

Device Recall Triathlon AR 4:1 Cutting Blocks
  • 모델명 / 제조번호(시리얼번호)
    Catalog no. 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, 7541-0-708. All lot codes.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Triathlon AR 4:1 Cutting Blocks - Size 1-8; || Catalog Numbers: 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, & 6541-0-708; || Triathlon MIS Instruments; || Non Sterile || Stryker Orthopaedics || 325 Corporate Drive || Mahwah, NJ 07430 || The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component.
  • 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