Events

Device Recall Kerr Maxcem Elite 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical 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
    64559
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1076-2013
  • 사례 시작날짜
    2013-02-22
  • 사례 출판 날짜
    2013-04-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116486
  • 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
    Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
  • 원인
    Kerr corporation is initiating this recall because raw material used to produce the maxcem elite is causing the material to prematurely polymerize in the syringe. the product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. as a result, the restoration may not be seated properly.
  • 조치
    The firm, Kerr Corporation/Sybron Dental Specialties, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 22, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers are instructed to determine if you have any of the affected products in your inventory; If you have the affected lots, please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number for quick return; complete and return the Maxcem Elite Acknowledgement and Recall Return Form via fax to 714-288-4609 regardless of whether you have any product in your inventory. If you are an authorized Kerr Corporation distributor, identify and contact those customers that may have been shipped the affected product within 48 hours of receipt of this field correction notification. If you have any question, contact Kerr Customer Care at 1-800-537-7123.

Device

Device Recall Kerr Maxcem Elite
  • 모델명 / 제조번호(시리얼번호)
    34417 KIT- MAXCEM ELITE INTRO 2-4662052 4672087 4694484 4698107 4710901 4719936 4725775 4725776 34418 KIT - MAXCEM ELITE BULK-4706738 4656479 4656480 4666810 4666811 4666813 4668612 4709788 4710900 4712887 4725780 4729919 4734053 4744195 SYRINGE LOT NUMBERS 34417 & 34418 SYRINGE- MAXCEM ELITE CLEAR Individually affected syringes within Kits listed above-4663716 4663717 4690551 4690552 4704821 4728088 4741721 33872 REFILL- MAXCEM ELITE CLEAR-4664825 4669840 4669841 4672089 4676812 4676815 4678974 4678975 4690548 4690549 4690550 4702597 4710904 4710905 4718097 4720553 4720555 4720558 4720560 4720562 4720563 4720564 4720565 33873 REFILL- MAXCEM ELITE WHITE-4681749 4699954 4704804 4720556 4720567 4720568 4720569 4720573 4720574 4720575 33874 -REFILL- MAXCEM ELITE WHITE OPAQUE-4720576 4720577 4720578 4720579 4720580 33875-REFILL- MAXCEM ELITE YELLOW -4652147 4696832 4720198 33876 -REFILL- MAXCEM ELITE BROWN -4710907 4725879 34055 MAXCEM ELITE STANDARD KIT-4620128 4656894 4680372 4709328 4728932 4732387 4733719 4735545 4748933 4759314 34056 -MAXCEM ELITE VALUE KIT-4719214 4759315 4698814 34057 -MAXCEM ELITE MINI KIT-4709329 4714775 4728934 4732388 4756503 34058 MAXCEM ELITE REFILL CLEAR-4628189 4728840 4728844 4728935 4730842 4732144 4735257 4735546 4748934 4756504 34059 -MAXCEM ELITE REFILL WHITE-4705713 4728936 4745082 4756505 34060 MAXCEM ELITE REFILL WHITE OPAQUE-4719215 4735547 4768408 34061 MAXCEM ELITE REFILL YELLOW -4700948 4705714 4728937 4756506 4768409 34062 MAXCEM ELITE REFILL BROWN -4709330 4738886 4749728 MAXCEM ELITE CLEAR FILLED SYRINGE-4679149 4679150 4681816 4681817 4685882 4685882 4694026 4694026 4694028 4694030 4708393 4708393 4717716 4721155 4733694 4741330 4756672 4756673 4766817 MAXCEM ELITE WHITE OPAQUE FILLED SYRINGE -4684879 4685879 4733678 MAXCEM ELITE YELLOW FILLED SYRINGE -4689433 4689433 4693134 4693134 4717719 4743042 4770898 MAXCEM ELITE BROWN FILLED SYRINGE -4708392
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Belgium, Czech Republic, France, Great Britain, Poland, Albania, Austria, Bulgaria, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, Croatia, Hungary, Ireland, ITtaly Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Serbia (Republic of Serbia), Sweden, Slovenia, Turkey, Ukraine, United Arab Emirates, Congo, The Democratic Republic of the (formerly Zaire), Kazakhstan, Lebanon, Russian Federation, South Africa, Mexico, Thailand, Brazil, China, Hong Kong, Israel, India, Japan, Malaysia, Panama, Singapore, Viet Nam.
  • 제품 설명
    Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. || Used for cementation of all indirect restorations.
  • Manufacturer
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

Manufacturer

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
  • 제조사 주소
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, 1717 W Collins Ave, Orange CA 92867-5422
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA