Device Recall Oto Flex Bur

  • Model / Serial
    Part No. 31-55631, lot number 27066500 Part No. 31-55632, lot number 27111700 Part No. 31-55642, lot number 27135800 Part No. 31-55647, lot number 27123300
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Product was distributed to hospitals in the follwoing US states: CO, VA, MA, CA, HI, ID, VT, NY, NC, OK, MO, TX, GA, AND AL. there were no military or government accounts. There were nine international accounts as follows (all distributors): 1- Kir-Op AS, Biskop Jens Nilssonsgt 5A, Postal Box 6631 Etterstad 0607 Oslo, Norway. 2- Kebo Care Dema, Jerholmen 41, DK 2650 Hvidovre Denmark 3- Biomedical Technology, Via Tolstoi 7, 20090 Trezzano Sul, Nabiglio, Milan Italy. 4-Apex Medical Est. Jawad Sikkarieh Bldg., Sweifeh Amman 111121, PO Box 213131 Jordan 5- Diseven, Carrera 12 No 102-07 Santafe de Bogota Colombia; 6- Wise Horse, 10F-1 No. 11, Minchuan, Taipei, Taiwan 7- Medtronic Xomed, Unit 2/446 Victoria Road, Gladesville NSW Australia 8- Medtronic Xomed France, Saint Aubin Le Monial, 03160 Bourbon L''Archambault France 9- Medtroni BV Earl Bakenstraat 10, 6422 P J Heerlen, PO BNox 25880 6401 Db Heerlen, The Netherlands
  • Product Description
    Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: || Part Number 31-55631 Oto-Flex carbide 1.0mm Bur; || Part Number 31-55632 Oto-Flex carbide 2.3mm Bur; || Part Number 31-55642 Oto-Flex diamond 2.3mm Bur; || Part Number 31-55647 Oto-Flex diamone 0.7 mm Bur || PART NUMBER AND LOT NUMBER IS LISTED ON POUCH AND BOX LABEL.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Medtronic Xomed, Inc., 6743 Southpoint Dr, N., Jacksonville FL 32216
  • Source