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-1145-2016
  • 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=143757
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • 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.: 61890322 62213292 62215053 62277522 62402117 61921671 62207256 62212215 62241126 62251893 62268498 62281865 62396132 62402115 62024672 62176459 62210646 62215051 62221907 62241128 62241129 62266480 62277523 62402113 62402114 62406796 62202293 62218187 62255246 62281866 62354788 62396145 62406802 61882636 61890326 61942630 61943368 61957706 61957708 61957709 61968019 61983748 61983749 62109144 62109145 62143889 62163554 62173374 62176463 62188368 62197359 62197360 62197361 62204040 62204041 62204042 62204632 62204633 62204634 62207259 62210647 62210648 62213295 62221909 62221910 62226817 62233573 62238101 62241131 62241135 62241136 62241137 62241139 62241142 62241144 62241145 62251896 62251897 62251898 62251899 62251901 62255247 62266481 62266482 62277524 62284060 62352923 62358047 62383751 62383752 62383753 62383754 62386984 62386985 62402212 62402217 61882637 61885966 61889305 61976198 62147389 62170705 62191282 62197358 62199480 62199481 62210649 62210650 62218188 62218189 62218190 62236577 62236578 62241147 62251895 62258978 62260179 62260180 62352924 62358045 62388057 62402126 62402213 61890327 61968020 62170708 62188373 62207257 62207258 62226818 62241149 62241150 62251902 62258976 62268506 62383758 62383759 62396119 62396120 62396121 61980814 62170709 62202294 62202295 62236582 62258974 62260181 62260182 62352926 62358046 62383761 62396133 61976203 62170710 62176464 62191285 62193578 62221912 62226823 62241152 62250619 62251903 62265335 62354787 62396122 62396123 62403713 62406785 61885968 61980816 62167449 62198732 62202296 62218192 62241154 62266483 62354789 62389394 62389395 62402214 61919746 62170712 62207260 62226819 62226820 62251112 62265336 62383760 62402140 62406770 61882639 61980817 62167448 62218193 62266484 62396135 62403714 62406808 61882640 62199479 62233574 62258975 62396149 61980818 62238099 62354790 62402121 62406806 62221914 62402116 62255245 62402122 62268507 62406810 62188377 62258972 62260183 62402118 62183219 62193583 62354791 62406803 61815148 62080364 62154619 62180252 62193580 62193581 62226821 62226822 62241155 62241156 62251113 62268508 62316411 62383755 62383757 62396134 62402112 62406794 62402123 62213294 62215054 62396142 62406786 62354792 62406804 62233572 62406807 62163545 62395778 62202292 62241114 62198725 62226816 62241115 62268495 62389251 62389252 62198722 62218184 62268496 62395770 62406805 62218185 62277521 62395775 62406812 62395776 62281868
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 47 consists of all product under product code: LPH and same usage: || Item no: || 611004022 MODULAR CUP 10 DEGREE LIN || 611004428 MODULAR CUP 10 DEGREE LIN || 611004628 MODULAR CUP 10 DEGREE LIN || 611004828 MODULAR CUP 10 DEGREE LIN || 611004832 MODULAR CUP 10 DEGREE LIN || 611005028 MODULAR CUP 10 DEGREE LIN || 611005032 MODULAR CUP 10 DEGREE LIN || 611005628 MODULAR CUP 10 DEGREE LIN || 611005632 MODULAR CUP 10 DEGREE LIN || 611005828 MODULAR CUP 10 DEGREE LIN || 611005832 MODULAR CUP 10 DEGREE LIN || 611006028 MODULAR CUP 10 DEGREE LIN || 611006032 MODULAR CUP 10 DEGREE LIN || 611006228 MODULAR CUP 10 DEGREE LIN || 611006232 MODULAR CUP 10 DEGREE LIN || 611006428 MODULAR CUP 10 DEGREE LIN || 611006432 MODULAR CUP 10 DEGREE LIN || 611006628 MODULAR CUP 10 DEGREE LIN || 611006832 MODULAR CUP 10 DEGREE LIN || 611007028 MODULAR CUP 10 DEGREE LIN || 612004626 MODULAR CUP 20 DEGREE LIN || 612004628 MODULAR CUP 20 DEGREE LIN || 612004828 MODULAR CUP 20 DEGREE LIN || 612004832 MODULAR CUP 20 DEGREE LIN || 612005028 MODULAR CUP 20 DEGREE LIN || 612005032 MODULAR CUP 20 DEGREE LIN || 612005628 MODULAR CUP 20 DEGREE LIN || 612005828 MODULAR CUP 20 DEGREE LIN || 612005832 MODULAR CUP 20 DEGREE LIN || 612006028 MODULAR CUP 20 DEGREE LIN || 612006032 MODULAR CUP 20 DEGREE LIN || 610504428 MODULAR CUP NEUTRAL LINER || 610504832 MODULAR CUP NEUTRAL LINER || 610505028 MODULAR CUP NEUTRAL LINER || 610505032 MODULAR CUP NEUTRAL LINER || 610505632 MODULAR CUP NEUTRAL LINER || 610505832 MODULAR CUP NEUTRAL LINER || 610506032 MODULAR CUP NEUTRAL LINER || 610506232 MODULAR CUP NEUTRAL LINER || For use in total hip arthroplasty
  • 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