Events

Device Recall Comprehensive Segmental Revision System 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
    79399
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1173-2018
  • 사례 시작날짜
    2018-02-28
  • 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=162212
  • 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, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
  • 원인
    Zimmer biomet received reports that during assembly, an srs humeral distal body implant failed to engage correctly at the point of reduction with a discovery elbow system humeral condyle. a mismatch occurred between the screw holes in the distal humeral body & the discovery elbow condyle implant during vendor machine operation. the condition would be noticed during assembly and therefore, if the product has already been implanted, no further action is required. the mismatch does not always prevent engagement of the screw, based on complaints received it is estimated to prevent engagement of the screw in less than 1% of cases.
  • 조치
    An URGENT MEDICAL DEVICE RECALL letter will be issued to customers titled "Affected Product: Comprehensive Segmental Revision System (SRS)" instructing customers to do the following: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 2  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Device

Device Recall Comprehensive Segmental Revision System
  • 모델명 / 제조번호(시리얼번호)
    Model numbers: 211250 211251 211252 211253 211254 211255  Lot codes: 095580 119120 130020 142530 155910 162450 162460 241160 257860 304290 305860 309730 337610 389790 400730 419380 430570 443670 545430 546260 548290 550390 586120 606830 611540 636370 636470 688540 704020 714760 793670 806070 829520 829530 881230 950270 970920 019600 110780 130040 157180 185620 203520 241180 278580 330870 364380 424550 430580 457210 544340 583360 636520 706690 714810 810260 853250 881330 883830 891880 923660 923680 991400 033700 053800 062210 110790 160770 185630 241190 247810 257870 347080 583370 611530 636680 638640 674650 688550 775020 829540 848530 889330 950310 976390 988380 991410 028450 028460 053810 062220 098020 155900 160780 231490 241230 251120 251920 257880 281140 330880 347100 367850 400390 450780 493220 494170 527200 546290 548460 548470 548580 586130 611520 636710 665880 704030 761210 829550 853260 889810 914750 923670 923690 925920 927420 937130 991320 062830 119130 130070 185590 196660 201270 241290 247280 247290 257890 338480 347110 350590 366310 554450 636760 648150 704040 714830 750840 767880 793710 829560 878430 927430 948090 952960 970930 976410 040470 192770 241300 258540 288580 293740 320100 340150 347700 364660 419900 442840 462480 462490 569770 611040 611930 688560 770690 780490 815100 818160 829690 867530 891270 923980 924160 927440
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationally
  • 제품 설명
    Comprehensive Segmental Revision System (SRS)
  • 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