Events

Duracon Total Knee Distal Femoral Locking Screw 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
    50100
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0014-2011
  • 사례 시작날짜
    2006-10-05
  • 사례 출판 날짜
    2010-10-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74722
  • 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
    Knee Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code JWH
  • 원인
    Stryker orthopaedics became aware that a box labeled as duracon total knee distal femoral locking screws for 5 mm spacer, may actually contain a 10 mm screw.
  • 조치
    Important Market Withdrawal Letters were sent via Federal Express October 5, 2006. The letters identified the affected product and the reason for recall. Customers were asked to examine their inventory to identify the product; and retrieve all affected product lots and return it their branch or agency warehouse for reconciliation. All product should be reconciled on the Product Accountability Form and the form should be faxed back. Customers are to contact a Customer Service Rep to re-order the product that is being returned. Questions can be directed to Rita Intorrella on 201-831-5825.

Device

Duracon Total Knee Distal Femoral Locking Screw
  • 모델명 / 제조번호(시리얼번호)
    Lot Code: LADLF
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- Including Ohio.
  • 제품 설명
    Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. || Made in Ireland; || Howmedica Osteonics; || 325 Corporate Drive, || Mahwah, NJ 07430 || Intended for primary or secondary reconstruction of the distal femur.
  • 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