FDA-Device2018-07-25Class II
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
NewDeal SA
Hazard
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
Sold states
CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
Manufactured in
Immeuble Sequoia 2 97 A, 97 Allee Alexandre Borodineimmeuble Sequoia 2 97 Allee Alexandre Borodine, St Priest, France
Products
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2447-2018Don't want to check this manually?
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