Events

Device Recall DePuy Offset Wire Fixation Bolt used in AceFischer External Fixation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Orthopaedics, Inc. 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
    60325
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0508-2012
  • 사례 시작날짜
    2011-11-08
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105036
  • 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
    Holder, needle; Orthopedic - Product Code HXK
  • 원인
    Depuy has received three complaints concerning oversized bolt threads in the offset wire fixation bolts used in the ace- fischer external fixation system. this could lead to the inability to properly thread the nut onto the bolt.
  • 조치
    On 11/9/2011 DePuy sent "Medical Device Recall Notice" letters to Distributors and to direct account hospitals. Recall notices included instructions to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN via distributors and sales representatives. The product is going to be discontinued and no reconditioning or reworking for the product is planned. For questions about recall information provided, please contact Katie Seppa, Manager of Customer Quality, 574-372-7333 (M-F; 8 am - pm EST.)

Device

Device Recall DePuy Offset Wire Fixation Bolt used in AceFischer External Fixation System
  • 모델명 / 제조번호(시리얼번호)
    Catalog: 8180-50-006, Lot numbers: 549490, 563542, 563543, 564885, 564886, 570133, 571504, 573502, 581088, 581439, and 582520.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • 제조사 주소
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA