Events

DePuy Mitek Tissue Liberator Blade Up 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Mitek, Inc., a Johnson & Johnson Co. 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
    64913
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1278-2013
  • 사례 시작날짜
    2013-04-15
  • 사례 출판 날짜
    2013-05-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117373
  • 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
    Accessories,arthroscopic - Product Code NBH
  • 원인
    Labeled incorrectly as a blade up configuration instead of a blade down configuration.
  • 조치
    DePuy Synthes sent an Urgent Voluntary Product Recall letter dated April 15, 2013, to all affected customers. The letter iidentified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check all inventories to locate and return the affected product. For returns customers were instructed call 1-877-379-4871 to obtain a goods authorization (RGA) number. Affected product should be returned to: Mitek Sports Medicine ATTN: Mitek Complaints 325 Paramouont Drive Rayham, MA 02067 For questions customers were instructed to call 1-877-379-4871.

Device

DePuy Mitek Tissue Liberator Blade Up
  • 모델명 / 제조번호(시리얼번호)
    Lot number:13A01
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions regarding this recall call 508-977-3813.
  • 제품 설명
    DePuy Mitek Tissue Liberator -Blade Up || Catalog Number: 214623 || The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • 제조사 주소
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Drive, Raynham MA 02767-5199
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA