Device Recall Firebird Spinal Fixation System

  • 모델명 / 제조번호(시리얼번호)
    BS535418105, BS535419118, BS535420030,  BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039,  BS535418127,  BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and  BS562325023.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Spain, Italy, and Australia.
  • 제품 설명
    Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) || Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
  • 제조사 모회사 (2017)
  • Source
    USFDA