Events

Device Recall Medline Anterior Cervical Distraction Pin 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MEDLINE INDUSTRIES 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
    76298
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2105-2017
  • 사례 시작날짜
    2016-12-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152773
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Product's non-conformity involves the integrity of the seal in the sterile packaging. it is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
  • 조치
    Medline Industries sent an Immediate Action Required letter dated December 14, 2016, to all affected customers with response forms via US mail, notifying them of the recall. Customers were instructed to quarantine affected product and return it to the firm. The product will be repackaged and sterilized. Customers with questions were instructed to call 866-359-1704. For questions regarding this recall call 847-643-3245.

Device

Device Recall Medline Anterior Cervical Distraction Pin
  • 모델명 / 제조번호(시리얼번호)
    Item# MDS9091010; Lots #133115, 136754
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA || Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
  • Manufacturer
    MEDLINE INDUSTRIES INC

Manufacturer

MEDLINE INDUSTRIES INC
  • 제조사 주소
    MEDLINE INDUSTRIES INC, 3 Lakes Dr, Northfield IL 60093-2753
  • 제조사 모회사 (2017)
    Medline Industries Inc.
  • Source
    USFDA