Events

Device Recall Flower Orthopedics Variable Angle Locking Peg 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Flower Orthopedics 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
    70578
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1314-2015
  • 사례 시작날짜
    2015-02-16
  • 사례 출판 날짜
    2015-03-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134073
  • 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
    Locking pegs were not locking during distal radius procedures. there has been one (1) report of revision surgery scheduled to remove a loosened peg.
  • 조치
    On February 16, 2015, Flower Orthopedics generated and distributed a field memo/advisory notice (FOCMB-15-02) to all distributors with locking peg inventory on February 6, 2015. The field memo provided technique guidance to end users. All 12 consignees with remaining inventory (ie.not reported as used) were contacted directly via phone and all have agreed to ship the locking pegs back to Flower Orthopedics. Flower Orthopedics determined that a generic statement to all customers was not necessary for the following reasons detailed above and summarized again here: product was distributed only through direct channels, the health hazard evaluation has determined there is a very low risk to health, and all consignees have been directly contacted already and product inventory is being returned.

Device

Device Recall Flower Orthopedics Variable Angle Locking Peg
  • 모델명 / 제조번호(시리얼번호)
    All lots of Catalog Numbers:  FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
  • 제품 설명
    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. || The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.
  • Manufacturer
    Flower Orthopedics Corporation

Manufacturer

Flower Orthopedics Corporation
  • 제조사 주소
    Flower Orthopedics Corporation, 100 Witmer Rd Ste 280, Horsham PA 19044-2647
  • 제조사 모회사 (2017)
    Flower Orthopedics Corp.
  • Source
    USFDA