Device Recall Biotrak Resorbable Fixation System

  • 모델명 / 제조번호(시리얼번호)
    Lot W67385, Model #30170320-S, expiration 8/2010 (two side labels correctly state 30170320-S, Lot W67385; top label may incorrectly state 30170060-S, lot W67391).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA and South Africa.
  • 제품 설명
    Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Distributed by: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124. || The Acumed resorbable fixation devices are designed to provide fixation of specific fractures, osteotomies, and arthrodeses while they heal.
  • Manufacturer
  • 1 Event

제조사

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