Events

Device Recall Zimmer Natural Nail System Tear Drop Guide Wire 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
    79681
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1469-2018
  • 사례 시작날짜
    2018-03-26
  • 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=162974
  • 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
    Potential failure of sterile packaging seal.
  • 조치
    Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy. All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018. " Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. " Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter. " Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form. o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.

Device

Device Recall Zimmer Natural Nail System Tear Drop Guide Wire
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  63609177 63631715 63638172 63638173 63638175 63638176 63645643 63645644 63655990 63655991 63655992 63655993 63655994 63662538 63662539 63662540 63662541 63668694 63668695 63668696 63668697 63675668 63675669 63675670 63675704 63675705 63681724 63681726 63681728 63690176 63690179 63690180 63705228 63705229 63709163 63709164 63709165 63709166 63715680 63715681 63715682 63715683 63721368 63721369 63721370 63721371 63731169 63748392 63753760 63753761 63753762 63753763 63758420 63758421 63758422 63758423 63771066 63771067 63780119 63780120 63780121 63780122 63781875 63781876 63781877 63781878 63787475 63787476 63787477 63796531 63796532 63796533 63796534 63796535 63803579 63803581 63803583 63803591 63803592 63812281 63812283 63812284 63812285 63817702 63817704 63817705 63844026 63812282 63817701 63826234 63826235 63836285 63844028
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • 제품 설명
    Zimmer Natural Nail System Tear Drop Guide Wire || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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