Events

DRLock Volar Plate Screw System, model DVR900 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 OrthoHelix Surgical Designs 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
    36843
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0349-2007
  • 사례 시작날짜
    2006-08-03
  • 사례 출판 날짜
    2007-01-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49443
  • 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
    Plate Screw System distal radius of hand - Product Code HRS
  • 원인
    The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.
  • 조치
    The recalling firm contacted all consignees by phone on or about 8/3/06.

Device

DRLock Volar Plate Screw System, model DVR900
  • 모델명 / 제조번호(시리얼번호)
    Tray kit (case) set number: ''BAA'', ''BAB'', ''BAC'', ''BAD'', ''BAE'', ''BAF'',  ''BAH'', and ''BAJ''. (The distal locking-screws contained in the kit are identified with lot numbers S104 and S200)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The product was distributed to 5 consignees located in the U.S.: Archway Medical, Columbia, SC; Gulf Coast Surgical, Stafford, TX; Vaugham Medical, Wheat Ridge, CO; Belemy Medical, Cleveland, OH; and Crystal Clinic, Akron, OH.
  • 제품 설명
    DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: || 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires.
  • Manufacturer
    OrthoHelix Surgical Designs Inc

Manufacturer

OrthoHelix Surgical Designs Inc
  • 제조사 주소
    OrthoHelix Surgical Designs Inc, 1815 W Market St Ste 205, Akron OH 44313-7018
  • Source
    USFDA