Events

Device Recall Trilogy Cups 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Manufacturing B.V. 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
    69814
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0875-2015
  • 사례 시작날짜
    2014-12-04
  • 사례 출판 날짜
    2014-12-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131584
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • 원인
    Zimmer received a single complaint wherein a trilogy® fiber metal multi-hole acetabular shell would not attach to the inserter/impactor instrumentation. subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. investigation also indicates that the issue is isolated and affects only lot 62714305, which.
  • 조치
    The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" memo dated 12/4/2014 to its customers. The memo described the product, problem and actions to be taken. The customers were instructed to locate all product from the listed lot and quarantine them immediately; carry out a physical count of all affected product in inventory; complete and return the Inventory Return Certification Form via email to: corporatequality.postmarket@zimmer.com on or before 12/12/2014; return the recalled product along with Inventory Return Certification Form on or before 12/12/2014; keep and maintain a copy for your records; and notify Zimmer of any hospitals that you have further distributed the affected product to and complete spreadsheet template provided. After reviewing this notification you have further questions or concerns, call the customer call center at 1-800-348-2759 between 8:00 am and 5:00 pm EST.

Device

Device Recall Trilogy Cups
  • 모델명 / 제조번호(시리얼번호)
    Item No. 00-6200-054-20; Lot 62714305
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and United Kingdom.
  • 제품 설명
    Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD || The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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