Synthes Inflation System — Class II medical device recall Z-0877-2015
Terminated recall by PEROUSE MEDICAL, reported 2015-01-07, distributed nationwide. Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may
| Recall number | Z-0877-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PEROUSE MEDICAL, Ivry Le Temple, N/A, France |
| Recall initiated | 2014-10-06 |
| Classified | 2014-12-29 |
| Reported by FDA | 2015-01-07 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 2,184 units |
| Lot numbers | 4041354/4062650/4072586 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0877-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.