Events

Device Recall Zimmer 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
    72900
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1118-2016
  • 사례 시작날짜
    2016-01-11
  • 사례 출판 날짜
    2016-03-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143669
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • 원인
    As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
  • 조치
    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Device

Device Recall Zimmer
  • 모델명 / 제조번호(시리얼번호)
    lot no.: 61678184 61839111 61852988 61862260 61875843 61882261 61898918 61974385 61988314 62002243 62002244 62024181 62031621 62090117 62109252 62263147 61875838 61895890 61895891 61912706 62037827 61649744 61660679 61764382 61882257 61887223 61988311 61988312 61988313 62009735 62037784 62090119 62109257 62153293 62160886 62263160 62109261 61396164 61634704 61664774 61777417 61777418 61782841 61782843 61782845 61782848 61810565 61810566 61810567 61810568 61810569 61810570 61810571 61839106 61839107 61839108 61839109 61852999 61853001 61853002 61853005 61875839 61875854 61882265 61887219 61887220 61893994 61894002 61915563 61915564 61915565 61938456 61938457 61938458 61938459 61980692 61980694 61980696 61980698 61985662 61985665 61985670 61985676 62009730 62009731 62009732 62009734 62017442 62017443 62017444 62024184 62024185 62024186 62031633 62038976 62038977 62038978 62090115 62097349 62097351 62097353 62120586 62120587 62120589 62120590 62120593 62134879 62134889 62134890 62150227 62150230 62150231 62153290 62153291 62153292 62160882 62160884 62193769 62193770 62193771 62204429 62204430 62204431 62204432 62204433 62263150 62263153 62263156 62263158 61649748 61782622 61782623 61782839 61810563 61810564 61839110 61852991 61852993 61875841 61875849 61882258 61887216 61887217 61898919 61985648 61985652 61985656 62002245 62002246 62002247 62009728 62009729 62024182 62024183 62031630 62090118 62118596 62134877 62150234
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 20 consists of all prod oct under poduct code: KTT and same usage: || Item no: || 47116201900 COMPRESSION SCREW 1/2IN || 47116202300 COMPRESSION SCREW 1-1/2IN || 47116202200 COMPRESSION SCREW 1-1/4IN || 47116202400 COMPRESSION SCREW 1-3/4IN || 47116202100 COMPRESSION SCREW 1IN || 47116202000 COMPRESSION SCREW 3/4IN || Product Usage: || Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • 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