Events

Device Recall Cutting Edge Acetabular Spherical Reamer 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
    61715
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1618-2012
  • 사례 시작날짜
    2011-12-23
  • 사례 출판 날짜
    2012-05-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108777
  • 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
    Reamer - Product Code HTO
  • 원인
    A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field.
  • 조치
    Stryker sent an "URGENT PRODUCT RECALL" letter dated December 29, 2011 to all affected customers. Notification letters and Product Accountability Forms were sent to Stryker accounts via FedEx on January 3, 2012 with return receipt. Hospital Risk Management and Chief of Orthopaedics Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Surgeon Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Notification sent via e-mail toCanada.EMEA, LatinAmerica.Asia Pacific on December 23, 2011. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to return the affected product. A Product Recall Acknowledgment Form was attached to the letter for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.

Device

Device Recall Cutting Edge Acetabular Spherical Reamer
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 2102-0444 Lot number V2010068 No 510 K number No expiration date
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. || The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Spherical Reamer that is 4mm smaller than the templated or gauged size of the planned shell. Per the procedures, reaming should increase in size by 1mm increments until final sizing is achieved. Surgical judgment is used to assess bone stock, bone quality, desired level of press fit, and proper amount of reaming.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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