Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventiona
FDA device recall Z-0877-2015 · posted 2014-12-29 · Terminated
Recall details
- Recalling firm
- PEROUSE MEDICAL
- 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
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MAV
- Quantity affected
- 2184 units
- Distribution
- US Nationwide Distribution in the states of AZ and CO.
- Date initiated
- 2014-10-06
- Date posted
- 2014-12-29
- Date terminated
- 2017-03-24
- Location
- Ivry Le Temple, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VBB SYSTEM (K110604) | Synthes | 2011-12-13 |