Device Recall LINVATECArthroscopic Blade

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 193794 and 193534.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, and WY, and the country of Canada.
  • 제품 설명
    ***CAT#: 9297A***LINVATEC***Arthroscopic Blade***4.8mm GREAT WHITE, 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 193794***Expiration Date: 10/2011. || ***CAT #: 9299A***LINVATEC***Arthroscopic Blade***4.2mm GREAT WHITE, 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 193534***Expiration Date: 10/2011. || Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ascent Healthcare Solutions, 10232 S 51st St, Phoenix AZ 85044-5205
  • 제조사 모회사 (2017)
  • Source
    USFDA