Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphop...
FDA Device Recall #Z-0877-2015 — Class II — October 6, 2014
Recall Summary
| Recall Number | Z-0877-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 6, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PEROUSE MEDICAL |
| Location | Ivry Le Temple, N/A |
| Product Type | Devices |
| Quantity | 2184 units |
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
Distribution Pattern
US Nationwide Distribution in the states of AZ and CO.
Lot / Code Information
Batch numbers: 4041354/4062650/4072586
Other Recalls from PEROUSE MEDICAL
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1891-2017 | Class II | DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVI... | Apr 5, 2017 |
| Z-0876-2015 | Class II | Bard Caliber (CL3030) Inflation Device Prod... | Oct 6, 2014 |
| Z-2089-2014 | Class II | Perouse Flamingo, Model 0218TA and 0218TB inten... | May 10, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.