Z-0877-2015Class II

Synthes Inflation System (03.804.4135)

Name: Z-0877-2015 Synthes Inflation System (03.804.4135)
Creator: Perouse Medical
Published: 2014-10-06
License: https://open.fda.gov/license/

Perouse Medical / initiated 2014-10-06 / Terminated / root cause: design

FDA source

PEROUSE MEDICAL began a recall of Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional... on 2014-10-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0877-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Posted: 2014-12-29
Terminated: 2017-03-24
Recalling firm: Perouse Medical
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
Product code: MAV Syringe, Balloon Inflation
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
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 2184 units
Distribution: US Nationwide Distribution in the states of AZ and CO.
Product codes and lots: Batch numbers: 4041354/4062650/4072586

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0877-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0876-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-29
Z-0877-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-29

Product code MAV

K110604Class IIVbb SystemSynthes / cleared 2011-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)