Events

Device Recall Straumann Standard Plus Implant 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Straumann 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
    61440
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1351-2012
  • 사례 시작날짜
    2012-03-12
  • 사례 출판 날짜
    2012-03-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108077
  • 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
    Accessories, implant, dental endosseous - Product Code NDP
  • 원인
    Mislabeled: vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 sp 10 rn instead of 04.8 sp 10 wn.
  • 조치
    Straumann sent a "FIELD CORRECTIVE ACTION NOTICE" dated March 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. Additionally, a Customer Confirmation Form was enclosed for customers to complete and return. Contact the firm at 978-747-2514 for questions regarding this notice.

Device

Device Recall Straumann Standard Plus Implant
  • 모델명 / 제조번호(시리얼번호)
    Lot No. CW642
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Straumann Standard Plus Implant 04.8mm Wide Neck || SLA 10mm || Article Number: 043.652S. || Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
  • Manufacturer
    Straumann USA, LLC

Manufacturer

Straumann USA, LLC
  • 제조사 주소
    Straumann USA, LLC, 60 Minuteman Rd, Andover MA 01810-1008
  • 제조사 모회사 (2017)
    Straumann Holding AG
  • Source
    USFDA