FDA-Device2015-01-07Class II
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter
PEROUSE MEDICAL
Hazard
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Sold states
US Nationwide Distribution in the states of AZ and CO.
Affected count
2184 units
Manufactured in
ROUTE DU MANOIR, N/A, Ivry Le Temple, N/A, France
Products
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0877-2015Don't want to check this manually?
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