Device Recall RESTORIS PST Offset Shell Impactor

  • 모델명 / 제조번호(시리얼번호)
    Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, and WI.
  • 제품 설명
    RESTORIS PST RIO Offset Shell Impactor || For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Plantation FL 33317-7424
  • 제조사 모회사 (2017)
  • Source
    USFDA