Events

Device Recall Straumann TSleeve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Straumann Manufacturing 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
    52231
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0320-2011
  • 사례 시작날짜
    2009-06-04
  • 사례 출판 날짜
    2010-11-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82576
  • 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
    Incorrect inner diameter of the t-sleeve.
  • 조치
    Strauman USA LLC notified the consignee by telephone on June 4, 2009, and sent an Urgent Device Recall letter dated, June 8, 2009 as a follow-up. The letter described the product, the problem, and the action to be taken by the customer. The customer was asked to return any affected product, in the prepaid preprinted mailer pouch as soon as possible to: T-sleeve Recall, Straumann USA, LLC 60 Minuteman Road Andover, MA, 01810 Customers were asked to sign and indicate on the Recall Acknowledgement Form if they would like a replacement product or a credit to their account for the product returned and fax the form to (978) 747-0023. For any questions regarding this recall call (978) 747-2575.

Device

Device Recall Straumann TSleeve
  • 모델명 / 제조번호(시리얼번호)
    Lot# R9483
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Canada
  • 제품 설명
    Straumann T-Sleeve 2.8mm, height 6mm, guided || Article Number: 034.055V46 || Intended for use as a drilling guide to prepare a site for placement of a dental implant into the dental implant site.
  • Manufacturer
    Straumann Manufacturing Inc.

Manufacturer

Straumann Manufacturing Inc.
  • 제조사 주소
    Straumann Manufacturing Inc., 60 Minuteman Rd, Andover MA 01810
  • 제조사 모회사 (2017)
    Straumann Holding AG
  • Source
    USFDA