Events

Device Recall Sharpoint 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 SSC- Surgical Specialties Corporation 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
    74230
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2042-2016
  • 사례 시작날짜
    2016-05-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146903
  • 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
    Suture, nonabsorbable, synthetic, polypropylene - Product Code GAW
  • 원인
    Surgical specialties is recalling sharpoint polyproplyene blue monofilament 6"/15cm 9-0 usp because it may contain black nylon 9-0 suture.
  • 조치
    A customer notification letter dated 5/20/16 was sent to all customers to inform them that Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture. Customers are instructed to complete the attached customer acknowledgement form and return via fax to Surgical Specialties' Quality Assurance department at (610) 404-4010 or return via email to kknappenberger@surgicalspecialties.com. Customers with any questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.

Device

Device Recall Sharpoint

Manufacturer

SSC- Surgical Specialties Corporation
  • 제조사 주소
    SSC- Surgical Specialties Corporation, 9993 Marconi Dr, San Diego CA 92154-7271
  • Source
    USFDA