Events

Device Recall Small Bone Innovations 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Small Bone Innovations 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
    68445
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2127-2014
  • 사례 시작날짜
    2014-05-19
  • 사례 출판 날짜
    2014-07-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127716
  • 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
    Screw, fixation, bone - Product Code HWC
  • 원인
    Small bone innovations (sbi) is recalling all lots of 3.0/4.0mm autofix" cannulated compression screw system sets, implants, and instruments to update the ifu.
  • 조치
    Small Bone Innovations sent an Urgent Medical Device Recall letter, dated May 19, 2014, to all affected customers. The letter that described the product problem, and the action to be taken by the customer. was sent to sales reps, stocking customers, and distributors. Customers were instructed that a copy of the IFU should be stored with each unpackaged AutoFIX 3.0/4.0mm Compression Screw Sets, Implants, or Instruments in their current inventory. Customers were instructed to return all packaged affected product which would be replaced by the firm with an updated IFU. A Federal Express return label was included to facilitate the return shipment. Customers were instructed to complete, sign, and return with the product the Return Material Authorization (RMA) document. For questions regarding this recall call 215-428-1791.

Device

Device Recall Small Bone Innovations
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.
  • 제품 설명
    Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments || Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.
  • Manufacturer
    Small Bone Innovations

Manufacturer

Small Bone Innovations
  • 제조사 주소
    Small Bone Innovations, 1380 S Pennsylvania Ave, Morrisville PA 19067
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA