Events

Device Recall 6 HOLE REGULAR DOUBLE Y PLATE 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
    58199
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2385-2011
  • 사례 시작날짜
    2010-07-28
  • 사례 출판 날짜
    2011-05-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98786
  • 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
    Plate, bone - Product Code JEY
  • 원인
    Biomet microfixation, jacksonville, fl is recalling their 1.5 6 hole reg double y, lots 785710, 753120, 693500 and 733600. this product is labeled as 01-7110-k (1.5 6 hole reg double y), however the package contains a 01-7112-k (1.5.6 hold long double y).
  • 조치
    The firm, Biomet Microfixation, sent an "URGENT MEDICAL SAFETY ALERT NOTICE" letter dated July 28, 2010 to its customers/distributors. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their stock and ensure that the plates were properly distributed into their trays and that they have the sufficient quantity of plates that they need. In addition, they were instructed to complete and return the attached Inventory Reconciliation form via fax to: Attn: Customer Relations Specialist at 904-741-9425 and notify the recipient of this notice, if they have further distributed the product. If you have any questions, please contact the Customer Relations Specialist at 800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.

Device

Device Recall 6 HOLE REGULAR DOUBLE Y PLATE
  • 모델명 / 제조번호(시리얼번호)
    LOTS: 785710, 753120, 693500 and 733600
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) including states of: FL, IN, KY, MT, NC, NE, NY, OH, TX, VA, and WI; and countries including: Argentina, Canada, Colombia, Czech Republic, Japan, Korea, Mexico, Norway, South Africa, Spain and Turkey.
  • 제품 설명
    ***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0.6 MM TITANIUM***NON-STERILE PRODUCT*** || This titanium plate is used in the 1.5mm Lorenz Midface System which is indicated for use in trauma, neurosurgery, craniomaxillary reconstruction and orthognathic procedures in the midface.
  • 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