Synthes Inflation System recall
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other…
Why was Synthes Inflation System 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch 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…
- Recalling firm
- PEROUSE MEDICAL
- Quantity
- 2184 units
- Distribution
- US Nationwide Distribution in the states of AZ and CO.
- Recall date
- January 7, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)