FDA Device recall Z-0877-2015
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or ot…
- FDA Device
- Class II
- terminated
- Published 2015-01-07
On 2015-01-07 the FDA classified a Class II recall of Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or ot… by Perouse Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0877-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-06 |
| Published | 2015-01-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Perouse Medical |
| Distribution | US |
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
Identifiers
| code_info | Batch numbers: 4041354/4062650/4072586 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0877-2015%22
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