Device Recall OPT Croutons synthetic bone substitute

  • 모델명 / 제조번호(시리얼번호)
    lot 549/12.001. Part number 65-0210-S.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
  • 제품 설명
    OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
  • Manufacturer
  • 1 Event

제조사

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