Events

Device Recall AXSOS PLUS LOCKING PLATE SYSTEM 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
    50850
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1062-2009
  • 사례 시작날짜
    2008-11-24
  • 사례 출판 날짜
    2009-04-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-04-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77488
  • 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
    AxSOS T8 Screwdriver - Product Code HRS
  • 원인
    Potential breakage: stryker orthopaedics became aware that there is the potential for the tip of the axsos screwdriver and the axsos torque limiter to break.
  • 조치
    "Urgent Product Recall" letters were sent to Stryker Orthopaedics Branches/Agencies, Chief of Orthopaedics, Hospital Risk Management and Surgeons on November 24, 2008 via Federal Express. The letters described the issue and provided the following instructions: 1. Examine your inventory and determine if you have any of the affected product, 2. Remove and quarantine affected product from your inventory, 3. Complete the attached Product Recall Acknowledgement Form (and fax to Stryker Orthopaedics at 201-831-6069), and 4. Return the affected product to your Stryker Orthopaedics Sales representative. Direct questions to your Stryker Orthopaedics Sales Representative or call Stryker Orthopaedics at 201-831-5000.

Device

Device Recall AXSOS PLUS LOCKING PLATE SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    All lot codes.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile. || Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. || The torque limiter is used for final tightening locking screws to the plate in order to avoid over tightening of the locking screws.
  • 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