Device Recall DYONICSArthroscopic Burr

  • Model / Serial
    Lot numbers: 197857 and 194244.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    ***CAT 7205330***DYONICS***Arthroscopic Burr, Wide Mouth***4.0mm STONECUTTER, 13cm long***Fits Power/EP-1 Motor Drives***Maroon***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 197857***Expiration Date: 12/2011. || ***CAT 7205331***DYONICS***Arthroscopic Burr, Wide Mouth***5.5mm STONECUTTER, 13cm long***Fits Power/EP-1 Motor Drives***Olive***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 194244***Expiration Date: 11/2011. || 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

Manufacturer

  • Manufacturer Address
    Ascent Healthcare Solutions, 10232 S 51st St, Phoenix AZ 85044-5205
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot number: 195769
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    ***CAT 7205326***DYONICS***Arthroscopic Burr, Wide Mouth***4.0mm ACROMIONIZER, 13cm long***Fits Power/EP-1 Motor Drives***Mauve***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 195769***Expiration Date: 11/2011. || 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