Events

Device Recall BIOMET MICROFIXATION Trauma One SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biomet Microfixation, 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
    52672
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1949-2009
  • 사례 시작날짜
    2009-02-16
  • 사례 출판 날짜
    2009-09-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-11-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83611
  • 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
    Bur, dental - Product Code EJL
  • 원인
    Biomet microfixation is recalling the 46-1004, trauma one drill, 18.X115 mm, 26 mm stop lot numbers 619450 and jc1002. the drills may be color-banded blue instead of brown. the color is a visual aid in determining what system the drill goes with. the blue indicates the drill is for the 2.0mm system. the brown indicates the drill is to be used for our 2.3mm system. the drill is etched and labe.
  • 조치
    Biomet Microfixation, Inc. issued an Urgent Medical Device Recall Notice dated February 19, 2009 via certified mail with return receipt. The notice informed users of the affected device and instructed them to immediately discontinue use and return to the firm. Consignees were also instructed to complete and return an Inventory Reconciliation sheet via fax to 1-904-741-9425. For further information, contact Biomet Microfixation, Inc. at 1-800-874-7711 or 1-904-741-4400.

Device

Device Recall BIOMET MICROFIXATION Trauma One SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 619450 and JC1002.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- Texas, Maryland, Florida, Washington DC, Michigan, Kansas Colorado and Missouri.
  • 제품 설명
    BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.
  • Manufacturer
    Biomet Microfixation, Inc.

Manufacturer

Biomet Microfixation, Inc.
  • 제조사 주소
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA