Events

Device Recall various polyethylene implants 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
    76507
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1860-2017
  • 사례 시작날짜
    2017-02-17
  • 사례 출판 날짜
    2017-03-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-01-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154309
  • 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
    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
  • 조치
    On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributors, Sales Representatives, and Distributor Operation Managers Your Responsibilities: 1. Review this notification and ensure affected team members 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. 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. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Clearly mark RECALL on the outside of return boxes. 5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and 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, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional

Device

Device Recall various polyethylene implants
  • 모델명 / 제조번호(시리얼번호)
    Items and lots: Item 11-105900 712480 Item 11-105901 695030 695040 Item 11-105902 309540 605110 605120 605130 712810 712830 712850 712860 Item 11-105911 577890 Item 11-105912 577920 Item 11-105913 577930 Item 11-105933 577950 Item 11-165208 779480 797810 Item 11-165216 905190 Item 11-165220 905230 Item 11-165222 808510 905270 920560 Item 11-165224 905130 Item 11-165226 758530 758550 797970 920600 Item 11-165228 879860 Item 11-165232 716050 732560 732580 920670 Item 11-165236 896290 Item 11-165240 779430 Item 12-105994 272230 Item CP162598 354160 Item EP-105833 371770 Item EP-105882 604860 Item EP-105894 371780 667310 Item EP-105914 371640 443510 443520 667250 667260 Item EP-105916 455050 577290 Item EP-105917 577300 Item EP-105918 577250 Item EP-105923 455070 577320 577340 728050 728080 728150 728180 Item EP-105925 577380 Item EP-105926 577390 Item EP-105933 455080 577360 Item EP-105934 604870 Item EP-105996 577420 Item EP-107926 811990 Item EP-108223 275040 Item EP-108322 371730 Item EP-108323 371740 667290 667300 Item EP-108424 272270 455100 Item EP-108425 455110 Item EP-108524 455120 Item EP-108525 240900 Item EP-176238 602380 Item EP-200144 455130 455150 728200 728220 Item EP-200146 390550 577450 577460 577480 Item EP-200148 511810 511820 511830 511840 511880 728230 728240 Item EP-200150 455180 455190 511890 511900 511910 728250 728270 Item EP-200152 455200 728300 728320 728340 Item EP-200154 455210 Item EP-200156 577490 577500 Item EP-200158 577510 577520 ItemEP-200160 455220 Item XL-105833 542210 542220 542230 542240 Item XL-105834 542250 Item XL-105835 614420 Item XL-105884 604960 Item XL-105885 588450 Item XL-105903 502330 502340 Item XL-105905 588490 Item XL-105914 502370 502380 Item XL-105923 290100 502390 502410 779270 Item XL-105924 309510 502430 502440 779340 Item XL-105925 502450 Item XL-105933 309520 502460 605000 779590 Item XL-105934 290110 502490 Item XL-105994 309530 Item XL-108222 290120 Item XL-108223 605040 Item XL-200144 605050 Item XL-200146 502590 644000 Item XL-200148 290130 502600 502610 Item XL-200150 502620 502630 Item XL-200152 502640 Item XL-200154 290140 Item XL-200158 502650 Item XL-200160 644030 Item XL-222846 290150 Item XL-223248 290160
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
  • 제품 설명
    various polyethylene implants || Hips || Active Articulation ArComXL Bearings || Active Articulation E1 Bearings || Arcos Taper Cap || BIOLOX delta Option Head || E1 RingLoc Bi-Polar || Freedom Constrained Liner +5mm || Hi-Wall ArcomXL All Poly || Rimloc E1 10 Degree Liner || RingLoc +3mm Hi-Wall E1 Liner || Ringloc +3mm Neutral Max-Rom ArComXL Liner || Ringloc +3mm Neutral Max-Rom E1 Liner || Ringloc +5mm Neutral Max-Rom E1 Liner || Ringloc 10 Degree ArCom Liner || Ringloc 10 Degree Face Changing ArComXL Liner || Ringloc 10 Degree Face Changing E1 Liner || RingLoc Bi-Polar || Ringloc Hi-Wall ArCom Liner || RingLoc Hi-Wall ArComXL Liner || RingLoc Hi-Wall E1 Liner || Ringloc Neutral Max-Rom ArCom Liner || RingLoc Neutral Max-Rom ArComXL Liner || RingLoc Neutral Max-Rom E1 Liner || Product Usage: || For use in hip arthroplasty
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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