Events

Device Recall Henry Schein Explorer Double End 5 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hu-Friedy Mfg Co, 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
    30882
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0528-05
  • 사례 시작날짜
    2005-01-07
  • 사례 출판 날짜
    2005-02-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36764
  • 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
    Explorer, Operative - Product Code EKB
  • 원인
    Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
  • 조치
    Hu-Friedy Mfg. Co., Inc. notified the Own Label Distributor of the recall on 1/7/05 by phone, and in writing on 1/10/05. Henry Schein, Inc. is having formal "URGENT: DEVICE RECALL" letters printed up which will be mailed to over 8100 of Schein's direct customers by First Class Mail on/about 1/21/05 to initiate the sub-recall of the dental explorers. Henry Schein will follow-up to non-responders by phone and/or fax.

Device

Device Recall Henry Schein Explorer Double End 5
  • 모델명 / 제조번호(시리얼번호)
    Date Codes/Lot Numbers: 0503, 0603, 0903, 1003, 1103. Barcode +H658100800808.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Dental practitioners, hospitals, dental clinics and distributors located nationwide, in Puerto Rico and internationally.
  • 제품 설명
    Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN¿ 100-8008 Explorer-Double End #5. +H658100800808. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).
  • Manufacturer
    Hu-Friedy Mfg Co, Inc.

Manufacturer

Hu-Friedy Mfg Co, Inc.
  • 제조사 주소
    Hu-Friedy Mfg Co, Inc., 3232 N Rockwell St, Chicago IL 60618-5944
  • Source
    USFDA