Events

Device Recall Triathlon Femoral Distal Fixation Peg 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
    57660
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1095-2011
  • 사례 시작날짜
    2010-12-22
  • 사례 출판 날짜
    2011-02-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96933
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 원인
    Stryker orthopaedics has become aware that the labels on the triathlon distal femoral fixation pegs contain an incorrect expiration date of january 2015 (2015-1) when the actual expiration date should read june 2014 (2014-6).
  • 조치
    The firm, Stryker, sent a "UPDATED (Corrected Lot Code) URGENT PRODUCT RECALL" letter dated January 6, 2011, via Fed Ex ,with return receipt to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to fax the attached Product Recall Acknowledgement form to (201) 831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product, and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team at (201) 831-5028.

Device

Device Recall Triathlon Femoral Distal Fixation Peg
  • 모델명 / 제조번호(시리얼번호)
    Lot #SMTFJ
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution.
  • 제품 설명
    Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. || One single unit to a package. || Triathlon Distal Femoral Fixation Pegs are made available separate from the Triathlon Posteriorly Stabilized Femoral Component. These distal femoral fixation pegs are an accessory to the Triathlon Femoral Component and are optional for use. These pegs are designed to provide rotational stability and to aid the surgeon in the placement of the femoral component on the prepared distal femur. The Triathlon Distal Femoral Fixation Pegs are fabricated from wrought cobalt alloy. The distal portion of the fixation peg is thread to allow the peg to be assembled to the distal threaded hole in the Triathlon femoral component. The proximal portion of the peg is recessed to allow the use of a wrench to assemble the peg into the femoral complement.
  • 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