Events

Device Recall ATN System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet, 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
    79408
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1233-2018
  • 사례 시작날짜
    2017-12-20
  • 사례 출판 날짜
    2018-03-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162248
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • 원인
    Zimmer biomet is conducting a medical device recall for the ace trochanteric nail (atn) system after a device performance review (dpr) failed clinical analysis for survivorship pursuant to the acceptance criteria for the dpr protocol for the atn system.
  • 조치
    On December 22, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers with a complete list of products subject to recall and requesting that the customer review the notification and notify all affected personnel of the recall. If there is affected product at the facility it is requested that these units be quarantined and returned to a sales representative for return to the firm. Questions or concerns can be directed to 574-371-3071.

Device

Device Recall ATN System
  • 모델명 / 제조번호(시리얼번호)
    903305060 903305065 903305070 903305075 903305080 903305085 903305090 903305095 903305100
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA (nationwide)
  • 제품 설명
    ACE Trochanteric Nail System || ATN AR SCREW 60MM STERILE || ATN AR SCREW 65MM STERILE || ATN AR SCREW 70MM STERILE || ATN AR SCREW 75MM STERILE || ATN AR SCREW 80MM STERILE || ATN AR SCREW 85MM STERILE || ATN AR SCREW 90MM STERILE || ATN AR SCREW 95MM STERILE || ATN AR SCREW 100MM STERILE || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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