Events

Device Recall Glenosphere Orientation Guide for the Delta XTEND Reverse Shoulder 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
    65081
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1520-2013
  • 사례 시작날짜
    2013-05-03
  • 사례 출판 날짜
    2013-06-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117855
  • 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
    Template - Product Code HWT
  • 원인
    The glenosphere orientation guide instrument used with the delta xtend reverse shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant.
  • 조치
    DePuy Synthes sent and Urgent Information - Medical Device Instrument Recall Notice letter dated May 3, 2013 via email to affected customers. The letter identified the affected product, problem, clinical implications, and potential adverse events. Arrangements will be made for all affected Glenosphere Orientation Guides (part #230795000/lot #5120443) to be returned. Customers were asked to return the response form via fax (574-371-4964). Product related questions should be directed to DePuy Synthes Joint Reconstruction (1-888-554-2482). Recall inquiries should be directed to Kim Earle, Recall Coordinator, 574-371-4917 (M-F; 8a.m.-5 p.m. EDT).

Device

Device Recall Glenosphere Orientation Guide for the Delta XTEND Reverse Shoulder System
  • 모델명 / 제조번호(시리얼번호)
    Part Number 230795000/Lot Number 5120443
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
  • 제품 설명
    DePuy Glenosphere orientation guide || Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
  • 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