Events

Device Recall TMJ SYSTEM InnerVuie SCOPE PROCEDURE KIT 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
    53584
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0532-2010
  • 사례 시작날짜
    2009-01-09
  • 사례 출판 날짜
    2009-12-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-03-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86644
  • 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
    Kit, Surgical Instrument, Disposable - Product Code KDD
  • 원인
    Biomet microfixation, inc. is recalling their onpoint tmj kit (part numbers 24-3050, 24-3055) and arthrosimplicity tmj arthocentesis kit (part numbers 922070, 922090, 922075). these two kits contain a bd sterile disposable 60 ml luer-lok syringe, part number 309653 which is under recall by becton dickinson (recall number z-2347-2008). becton dickinson has determined that unit package seal integ.
  • 조치
    Consignees were notified by a combination of telephone, fax, e-mail and certified mail. Questions related to this notice should be directed to Christy Cain at 1-800-874-7711.

Device

Device Recall TMJ SYSTEM InnerVuie SCOPE PROCEDURE KIT
  • 모델명 / 제조번호(시리얼번호)
    BP Syringe Codes 7298534, 7334153. Kit Lot # 617170, 617380,  617390,  617400,  617410,  617420,  617430,  617440,  617450,  617460,  617470,  617480,  617490,  617500,  617510,  617530,  620930,  620940,  620950,  620960,  623050,  623060,  623070,  623080,  623090,  623110,  623190,  623200,  623220,  632200,  637940,  658150,  674330,  674340,  674350,  674380,  674400,  674410,  674420,  674430,  674450,  674460, 674470,  674480, and 674490.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Product was distributed Internationally to Argentina, Denmark, Norway, and UK. Product was distributed domestically to AL, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, NC, OH, NY, PA, SC, TN, TX, UT, and VA.
  • 제품 설명
    BD Recalled component is labeled: || BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. || BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. || Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. || Component is found in: || TMJ SYSTEM InnerVuie SCOPE PROCEDURE KIT, REF 922090, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. || DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com || Kit contains individually packaged sterile products. || Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.
  • 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