Synthes Inflation System (03.804.4135) recallZ-0877-2015 · Perouse Medical · initiated Oct 6, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Perouse Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Device Design
What the company is doing
Perouse Medical notified Distributors by Safety Alert Letter sent on October 06, 2014 and and October 07, 2014 by e-mail. The letter identified the defective products and lot numbers and provided a description of the malfunction, risk and mitigation statements. US distributors have been requested to provide the required information to their customers. In addition, the firm has updated device instructions for use. The firm is requiring its customer to fill out a safety notice acknowledgement of receipt form.
Recall details
- Recall number
- Z-0877-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 6, 2014
- Posted by the FDA
- Dec 29, 2014
- Recalling firm
- Perouse Medical
- Quantity
- 2184 units
- Product code
- MAV
- FDA submissions
- K110604
- Distribution
- US Nationwide Distribution in the states of AZ and CO.
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
Code information (models, lots, serial numbers)
Batch numbers: 4041354/4062650/4072586
Other devices under the same FDA submission
1 device cleared under K110604 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 03.804.413SSynthes (U.S.A.) LP · CEMENT, BONE, VERTEBROPLASTY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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