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PEROUSE MEDICAL recalls Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interven
Recalled January 7, 2015 · FDA recall Z-0877-2015 · 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 · FDA Class II
Units
2184 units
Sold at
US Nationwide Distribution in the states of AZ and CO.
Description
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
Product
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
Manufacturer(s)
PEROUSE MEDICAL
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →