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Terminated

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

FDA Recall Z-0877-2015 · Posted 2014-12-29

Recalling FirmPEROUSE MEDICAL
Recall StatusTerminated
Product CodeMAV
Date Initiated2014-10-06
Date Terminated2017-03-24
Product Quantity2184 units

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution in the states of AZ and CO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110604VBB SYSTEMSynthes · 2011-12-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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