Recall Z-0877-2015— PEROUSE MEDICAL
Class II · Terminated
Class II FDA medical device recall by PEROUSE MEDICAL, initiated 2014-10-06, terminated 2017-03-24. It names one FDA 510(k) clearance: K110604. 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. Reason: 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.
- Recalling firm
- PEROUSE MEDICAL
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-06
- Terminated
- 2017-03-24
- Firm location
- Ivry Le Temple, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.