Device Recall The Polarus Plus Humeral Rod

  • 모델명 / 제조번호(시리얼번호)
    LOT 266220
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Italy, Ireland, and Great Britain.
  • 제품 설명
    The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus Humeral Fixation System Size: 8mm X 240mm Polarus Plus Humeral Rod***Titanium***REF HR-0824-S***LOT 266220***RX only***Manufactured or distributed by: ACUMED 5885 NW Cornelius Pass Road Hillsboro, OR 97124 USA***"
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • 제조사 모회사 (2017)
  • Source
    USFDA