PEROUSE MEDICAL recalls Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other intervention…

Recall date

October 6, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0877-2015

FDA classification

Class II

Brand / firm

PEROUSE MEDICAL

Sold / distributed

US Nationwide Distribution in the states of AZ and CO.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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