Events

Device Recall ROIA Anterior Delivery Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 LDR Spine USA, 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
    75068
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0045-2017
  • 사례 시작날짜
    2016-08-29
  • 사례 출판 날짜
    2016-10-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149274
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    The roi-a anterior delivery device t-handle, part number si-roia-0023 has experienced binding of the rotation of the t-handle. there have been no reports of patient injury.
  • 조치
    The firm, LDR, contacted affected consignees via phone and then sent a follow up email dated 9/8/16. The phone script and email described the product, problem and actions to be taken. The consignees were instructed to promptly return the instrument using the RMA#1180. The firm will perform a rework that prevents the binding to occur. If you have any question, contact the Quality Engineering Manager by email: ron.musselman@zimmerbiomet.com, phone: 512-344-3436 or Field Inventory Manager - US Supply Chain or phone: 512-344-3436.

Device

Device Recall ROIA Anterior Delivery Device
  • 모델명 / 제조번호(시리얼번호)
    Lot # 2295101A, 2295101A-R, 2296101A-R
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
  • 제품 설명
    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 || Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
  • Manufacturer
    LDR Spine USA, Inc.

Manufacturer

LDR Spine USA, Inc.
  • 제조사 주소
    LDR Spine USA, Inc., 13785 Research Blvd Ste 200, Austin TX 78750-1895
  • 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