Device Recall Nobel Replace Tapered Groovy RP 4.3x10mm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nobel Biocare USA LLC 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
    48702
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2240-2008
  • 사례 시작날짜
    2007-11-02
  • 사례 출판 날짜
    2008-09-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-09-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • 원인
    This recall was initiated after it was discovered that the nobelreplace tapered groovy rp 4.3x10mm, ref 32216 lot#403504 has an incorrect cap label. the affected lot has a cap label identifying the implant as "4.3x8". since this cap label may be the only means used for identifying the implant prior to surgery, it is possible that a user would try to use the 10mm implant as an 8mm implant.
  • 조치
    The recall was initiated on 11/02/2007 with telephone calls to the affected customers. A "Urgent Medical Device Recall" letter with attached Customer Response form was then sent via US Postal Service beginning on 11/02/2007. The letter instructed customers to please immediately remove and return REF 32216 Lot #403504, NobelReplace Tapered Groovy RP 4.3x10mm. The firm contracted UPS courier service to pick up the recalled products. Customers were also instructed if the have further distributed the affected product to please immediately notify those customer to cease using this particular lot and forward the customer this notice. The firm indicated in the recall notice that they are in the process of sending out replacement products. Contact Kam Leung at 714-282-4800 if you have questions.

Device

  • 모델명 / 제조번호(시리얼번호)
    Ref 32216 lot number: 403504
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    AR, AZ, CA, CO, FL, GA, IA, IL, MA, ME, MI, MO, NC, NC, NJ, NY, OK, PA, TX, UT, VA, WA
  • 제품 설명
    NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Nobel Biocare USA LLC, 22715 Savi Ranch Pkwy, Yorba Linda CA 92887-4609
  • 제조사 모회사 (2017)
  • Source
    USFDA