Device Recall Titanium Tack Starter Kit

  • Model / Serial
    Lot Numbers: K0207015, K0307007, K0407011, K0507007, K0507008, K0507010, K0607003, K0607008, K0607009, K0607017, K0707010, K0707014, K0907001, K0907009, K0907011, K1007006, K1007007, K1007008, K1107009, K1107010, K1107012, K1207002, K0208005, K0208005R, K0308003, 0800120, 0800450, 0800451, 0800674, 0801215, 0801256, 0801728, 0801894, 0802232, 0802528, 0803139, 0900023, 0900884, 0901727, 0902402, 0903145, 0903480, 1000059, 1001465, 1002292, 1004118, 1005055, 1100381, 1100806, 1101066, 1101555, 1102699, 1103390, 1103811, 1104079, 1104778, 1105636, 1200829, 1201978, 1202444, and 1203107
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Ecuador, Egypt, Fiji, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
  • Product Description
    Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. || Dental.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    BioHorizons Implant Systems Inc, 2300 Riverchase Ctr, Birmingham AL 35244-2808
  • Manufacturer Parent Company (2017)
  • Source
    USFDA