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-1165-2016
  • 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=143894
  • 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, cemented - Product Code JDI
  • 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.: 62012574 62076883 62082566 61866199 61874734 61893708 61899069 62022707 62028699 62030919 62042521 62051543 62060669 62075336 62079977 62079978 62079980 62113214 62114829 62114830 62122093 62128919 62128920 62132260 62140346 62148554 62160578 62163478 62188294 62222803 62222804 62223792 62240251 62240759 62240760 62246361 62246362 62246363 62258940 62260127 62261929 62261930 62284475 62284476 62314462 62317914 62320163 62327664 62330771 62331423 62340088 62354662 62354663 62360329 61823659 61832951 61866206 61866208 61873629 61881191 61886904 61889280 61890330 61891276 61896738 61901567 61901568 61952538 61953162 62010628 62027792 62028704 62028706 62028707 62035446 62042575 62050380 62051541 62051542 62058542 62060667 62060668 62079983 62079984 62097006 62097008 62103562 62103563 62103564 62122094 62122095 62122096 62125316 62127721 62127722 62128921 62128922 62132261 62132262 62137771 62137772 62137773 62143839 62143840 62148555 62154549 62154550 62154551 62160579 62163479 62181431 62181432 62181433 62194583 62206546 62222805 62222806 62223794 62227040 62227042 62240250 62240757 62240758 62246352 62246353 62246354 62246356 62246357 62246359 62246360 62256014 62256015 62262776 62262777 62264267 62264268 62267506 62268568 62278687 62278688 62278689 62281832 62291932 62291933 62291934 62298285 62298286 62299084 62305940 62315887 62315888 62317130 62317139 62317912 62317913 62320164 62327665 62328991 62328998 62328999 62329007 62329009 62333972 62333973 62333974 62333975 62340087 62346567 62346568 62346569 62346570 62352851 62352853 62360334 62362908 62362909 62362910 62362913 61843197 61878448 61881192 62012581 62030922 62082173 62140347 62151836 62256013 62262778 62284474 62303508 62325573 62340086 62354659 62354660 61815836 61870883 61876364 61878470 61881189 61882613 61884453 61901598 61977873 61977875 61977876 62024626 62024627 62024628 62036898 62038370 62042590 62050984 62050985 62058549 62065276 62073504 62073505 62094953 62094954 62094955 62094956 62094957 62112169 62112170 62112171 62114862 62114863 62134945 62134947 62154552 62154553 62161480 62161481 62178281 62178283 62181426 62181427 62181428 62193418 62203179 62203182 62204528 62204529 62215709 62224536 62227043 62227044 62234458 62234459 62240747 62240748 62270703 62284478 62284479 62284480 62291926 62291927 62298287 62298288 62317915 62320162 62326102 62330763 62330764 62330765 62333965 62333966 62333967 62333968 62339629 62339630 62339631 62345382 62345383 62345384 62345385 62352848 62360317 62360321 62360324 61884454 61884454N 370472 61866256 61876365 62024624 62058550 62076882 62114864 62167374 62194577 62207224 62227045 62270705 62291928 62312490 62340083 62358907
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 67 consists of all product under product code: JDI and same usage: || Item no: || 785001100 VERSYS ADVOCATE CEMENTED || 785001200 VERSYS ADVOCATE CEMENTED || 785001220 VERSYS ADVOCATE CEMENTED || 785001300 VERSYS ADVOCATE CEMENTED || 785001320 VERSYS ADVOCATE CEMENTED || 785001400 VERSYS ADVOCATE CEMENTED || 785001420 VERSYS ADVOCATE CEMENTED || 785001500 VERSYS ADVOCATE CEMENTED || 785001520 VERSYS ADVOCATE CEMENTED || 785001600 VERSYS ADVOCATE CEMENTED || 785001620 VERSYS ADVOCATE CEMENTED || 785001700 VERSYS ADVOCATE CEMENTED || 785001305 VERSYS ADVOCATE V-LIGN CE || 785001325 VERSYS ADVOCATE V-LIGN CE || 785001405 VERSYS ADVOCATE V-LIGN CE || 785001505 VERSYS ADVOCATE V-LIGN CE || 785001525 VERSYS ADVOCATE V-LIGN CE || For use in total or hemi 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