Device Recall M.U.S.T. Rod

  • 모델명 / 제조번호(시리얼번호)
    Lot #s 125212,144216, 148146
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
  • 제품 설명
    Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo || The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medacta Usa Inc, 3973 Delp St, Memphis TN 38118-6110
  • 제조사 모회사 (2017)
  • Source
    USFDA