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-1134-2016
  • 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=143740
  • 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
    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.: 61929352 61602065 61800233 61881344 61897089 61958884 61958885 61958886 61993617 62042512 62043576 62137020 62137021 62137022 62224312 61564745 61564747 61657666 61664936 61664937 61764346 61764347 61817406 61817407 61817408 61817409 61839143 61839144 61839145 61881305 61881306 61881307 61881322 61885590 61885592 61885593 61885594 61897083 61897084 61908110 61908114 61908115 61908116 61940081 61940086 61940088 61940090 61940092 61940093 61958887 61958888 61982446 61982447 62020899 62020900 62020901 62038717 62038721 62093613 62093615 62093617 62137023 62137024 62137025 62188625 62188626 62188627 61564754 61800242 61800243 61800244 61800245 61800251 61804379 61839148 61839149 61843698 61881323 61881328 61885595 61885596 61885598 61897085 61897086 61926555 61926556 61926558 61952708 61952709 61952710 61952711 61958889 61958890 61958891 61958892 61958893 61968087 61968088 61968090 62015514 62015520 62020902 62020903 62042513 62043577 62093623 62137026 62137028 62137029 62142069 62142072 62188628 62188629 62188638 62188640 62188643 61764348 61764349 61885603 61885605 61897087 61978180 61978181 61978182 61993618 62042514 62043578 62137030 62137032 61657688 61929353 61978183 61978184 62038740 62038741 62112767 62112769 61993622 62165490 61915262 61915263 61915264 62056670 62056673 62056674 62056675 62056676 62056677 62056678 62056679 62056680 62056681 62056682 62056683 62056684 62056685 62056686 62121124 62121125 62121126 62142063 62224315 62224317 62224320 62224321 62224322 62298604 61929356 61929357 62067205 62067217 62067222 62067225 62067228 62067229 62067241 62067242 62067244 62067245 62067246 62067253 62067255 62067257 62121153 62121154 62121155 62121156 62224328 62224329 62224330 62224331 62237601 62237605 62262081 62262081N 61993624 61915268 61915269 61915270 62130479 62130485 62130492 62130496 62130510 62130723 62130724 62130725 62130726 62137033 62137034 62237282 62237285 62237288 62237289 62237291 62237294 61993628 61915272 61915273 61915274 61915275 62129873 62129874 62129875 62129876 62129877 62129878 62129879 62129881 62137038 62165497 61915276 61915277
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 36 consists of all product under product code: HSB and same usage: || Item no: || 225302745 INTERLOCKING IM SCREW 4.5 || 225303045 INTERLOCKING IM SCREW 4.5 || 225303245 INTERLOCKING IM SCREW 4.5 || 225303545 INTERLOCKING IM SCREW 4.5 || 225303745 INTERLOCKING IM SCREW 4.5 || 225304045 INTERLOCKING IM SCREW 4.5 || 225304245 INTERLOCKING IM SCREW 4.5 || 225304545 INTERLOCKING IM SCREW 4.5 || 225305045 INTERLOCKING IM SCREW 4.5 || 225305245 INTERLOCKING IM SCREW 4.5 || 225305545 INTERLOCKING IM SCREW 4.5 || 225305745 INTERLOCKING IM SCREW 4.5 || 225306045 INTERLOCKING IM SCREW 4.5 || 225306545 INTERLOCKING IM SCREW 4.5 || 225307045 INTERLOCKING IM SCREW 4.5 || Product Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • 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