Events

Device Recall Synthes(R) Hemostatic Bone Putty 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes USA HQ, 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
    62592
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2206-2012
  • 사례 시작날짜
    2012-07-05
  • 사례 출판 날짜
    2012-08-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111111
  • 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
    Wax,bone - Product Code MTJ
  • 원인
    There is the potential for hemostatic bone putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
  • 조치
    The firm initiated their recall of this product on July 5, 2012 by sending a "Notice: Medical Device Recall" letter to their consignees. The letter identified the affected product along with the reason for recall; and, requested that consignees immediately cease using the product, examine their inventory, and remove the product from inventory. The letter further instructed consignees to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, and to complete and return the verification form that was included with the letter. Questions should be directed to 610-719-5450.

Device

Device Recall Synthes(R) Hemostatic Bone Putty
  • 모델명 / 제조번호(시리얼번호)
    All lot numbers associated with the identified part numbers.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US, including Washington, DC and states of AK, AZ, CA, CT, FL, GA, ID, KS, LA, MD, MA, MI, MN, MO, NE, NH, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI, and the country of Canada.
  • 제품 설명
    Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. || Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • 제조사 주소
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA