FDA-Device2015-04-22Class II
Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
Nobel Biocare Usa Llc
Hazard
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
Affected count
32 units
Manufactured in
22715/22725 Savi Ranch Pkwy, N/A, Yorba Linda, CA, United States
Products
Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1424-2015Don't want to check this manually?
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