Events

MDN Nails 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
    77141
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2595-2017
  • 사례 시작날짜
    2017-04-28
  • 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=155286
  • 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 initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
  • 조치
    Zimmer Biomet initiated a voluntary recall for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. Compromised packaging may result in surgical delays, possible infections, and revision surgeries due to infections. The firm distributed letters to customer via FED EX on 04/28/2017. Customers were instructed to do the following: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Note that any hospitals and/or surgeons that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager and Surgeon Recall Notice directly. Additionally, Zimmer Biomet will also notify surgeons that have implanted the affected product within the past 12 months. It is important that you review the list of hospitals and/or surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals and/or surgeons that may have received or used the affected product within the past 12 months. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified. 5. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet within 2 weeks. a. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. b. Include a

Device

MDN Nails
  • 모델명 / 제조번호(시리얼번호)
    510K: K965098,K142281,K962561  Item Numbers: 00224001048 00224001142 00224001144 00224001146 00224001148 00224001246 00224001248 00224001340 00224001342 00224001344 00224001346 00224001348 00224001434 00224001436 00224001438 00224001440 00224001442 00224001444 00224001446 00224001448 Lot Numbers: 60677568 60684983 60677568R 60684983R 60670026 60670026R 60645750 60645750R 60691655 60691655R 60711471 60711471R 60715081 60715081R 60725139 60725139R 60754804 60754804R 60747476 60747462 60747462R 60747477 60815078 60815079 60816181 60815078R 60815079R 60816181R 60816180 60816180R 60820253 367186 367189 60822094 367186R 367189R 60822094R 367810 367810R 60839006 60837666 60844163 60844196 60837666R 60844163R 60844196R 367869 367871 367869R 60848701 60854080 60848701R 60854080R 60854079 60854079R 367829 367829R 60859062 368307 368310 60859063 368310R 60859063R 368299 368302 368299R 368302R 368148 368143 368294 368294R 368297 368150 368298 368301 368305 368309 368298R 368301R 368309R 368562 367809 368531 368560 368561 368577 368580 368581 367809R 368560R 368581R 368530 368578 368582 368753 368517 368306 368575 368576 368306R 368575R 60919033 60919033R 60919035 60919035R 368340 368559 368340R 368559R 60960629 60960629R 60919039 60919039R 60967107 368149 61133054 61133054R 61140815 61140815R 61140818 61140819 61140818R 61140806 61140806R 61120929 61159207 61159207R 61172912 61175878 61175879 61175878R 61175879R 61143391 61178288 61143391R 61178288R 61172908 61172906 61172907 61172907R 61214457 61220918 61214457R 61220921 61228029 61220921R 61228029R 61206026 61206026R 61234881 61234881R 61244866 61244866R 61244870 61244870R 61266211 61266211R 61281343 61285992 61285992R 61290289 61290287 61290287R 61281344 61290286 61255582 61303822 61255582R 61298515 61294529 61332795 61303827 61303827R 61332793 61313784 61328171 61317759 61328170 61317759R 61328170R 61332794 61341157 61332794R 61338963 61338964 61357281 61357283 61357283R 61357280 61367359 61367361 61382442 61395133 61428549 61428549R 61475214 61475214R 61453190 61453194 61501069 61542230 61556956 61556957 61621133 370537 370519 370528 370588 370601 370602 370600 370676 370668 370682 370681 370677 37107639 62322143 62413175 37108737 37108740 37108731 62430032 45002782 62495894 37107661 37107515 62520406 62523522 62520407 37107521 62533618 37107523 37107657 37211418 37211705 37211951 37212517 37214483 37215822 37215823 37215824 37215825 37216452 37216810 37218034 37218265 37218692 37218874 37218875 37218879 37218880 37218881 37219144 62602659 37214456 37214482 37217395 62577102 37214480 62610838 37214452 62608435 37214457 37214474 37220504 37214475 37220497 37220505 37214464 37212807 37213531 37213532 37213538 37214459 62613231 37213062 37214458 37212168 37220496 37220506 37220507 37214481 37214476 37214484 37211555 37214465 37211249 37213927 37109144 62602670 37109319 37109327 37109329 37109348 37109350 37109332
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON DELIVERY SERVICE (LYNBROOK NY) MALAYSIA MEXICO MIAMI FL MOROCCO NETHERLANDS NEW ZEALAND NICARAGUA PANAMA PERU PHARR TEXAS POLAND PUERTO RICO RIO DE JANEIRO SAUDI ARABIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND THE NETHERLANDS TRIPOLI UK VIRGIN ISLANDS VA/DOD: Both see addresses below
  • 제품 설명
    R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, || 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
  • 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