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 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
Description du dispositif
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.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.