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-1144-2016
  • 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=143755
  • 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
    Screw, fixation, bone - Product Code HWC
  • 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)
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  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 46 consists of all product under product code: HWC and same usage: || Item no: || 114204012 MINI MAGNA-FX CANN SCREW || 114204016 MINI MAGNA-FX CANN SCREW || 114204020 MINI MAGNA-FX CANN SCREW || 114204024 MINI MAGNA-FX CANN SCREW || 114204028 MINI MAGNA-FX CANN SCREW || 114204032 MINI MAGNA-FX CANN SCREW || 114204036 MINI MAGNA-FX CANN SCREW || 114204040 MINI MAGNA-FX CANN SCREW || 114204044 MINI MAGNA-FX CANN SCREW || 114204048 MINI MAGNA-FX CANN SCREW || 114204055 MINI MAGNA-FX CANN SCREW || 114204065 MINI MAGNA-FX CANN SCREW || 114204124 MINI MAGNA-FX CANN SCREW || 114204126 MINI MAGNA-FX CANN SCREW || 114204128 MINI MAGNA-FX CANN SCREW || 114204130 MINI MAGNA-FX CANN SCREW || 114204132 MINI MAGNA-FX CANN SCREW || 114204134 MINI MAGNA-FX CANN SCREW || 114204136 MINI MAGNA-FX CANN SCREW || 114204138 MINI MAGNA-FX CANN SCREW || 114204140 MINI MAGNA-FX CANN SCREW || 114204142 MINI MAGNA-FX CANN SCREW || 114204144 MINI MAGNA-FX CANN SCREW || 114204146 MINI MAGNA-FX CANN SCREW || 114204148 MINI MAGNA-FX CANN SCREW || 114204150 MINI MAGNA-FX CANN SCREW || 114204155 MINI MAGNA-FX CANN SCREW || 114204160 MINI MAGNA-FX CANN SCREW || 114204165 MINI MAGNA-FX CANN SCREW || 114204170 MINI MAGNA-FX CANN SCREW || 114205012 MINI MAGNA-FX CANN SCREW || 114205016 MINI MAGNA-FX CANN SCREW || 114205020 MINI MAGNA-FX CANN SCREW || 114205024 MINI MAGNA-FX CANN SCREW || 114205028 MINI MAGNA-FX CANN SCREW || 114205032 MINI MAGNA-FX CANN SCREW || 114205036 MINI MAGNA-FX CANN SCREW || 114205040 MINI MAGNA-FX CANN SCREW || 114205044 MINI MAGNA-FX CANN SCREW || 114205048 MINI MAGNA-FX CANN SCREW || 114205055 MINI MAGNA-FX CANN SCREW || 114205065 MINI MAGNA-FX CANN SCREW || 114205124 MINI MAGNA-FX CANN SCREW || 114205126 MINI MAGNA-FX CANN SCREW || 114205128 MINI MAGNA-FX CANN SCREW || 114205130 MINI MAGNA-FX CANN SCREW || 114205132 MINI MAGNA-FX CANN SCREW || 114205134 MINI MAGNA-FX CANN SCREW || 114205136 MINI MAGNA-FX CANN SCREW || 114205138 MINI MAGNA-FX CANN SCREW || 114205140 MINI MAGNA-FX CANN SCREW || 114205142 MINI MAGNA-FX CANN SCREW || 114205144 MINI MAGNA-FX CANN SCREW || 114205146 MINI MAGNA-FX CANN SCREW || 114205148 MINI MAGNA-FX CANN SCREW || 114205150 MINI MAGNA-FX CANN SCREW || 114205155 MINI MAGNA-FX CANN SCREW || 114205160 MINI MAGNA-FX CANN SCREW || 114205165 MINI MAGNA-FX CANN SCREW || 114205170 MINI MAGNA-FX CANN SCREW || Product Usage: || A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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