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U.S. Department of Health and Human Services

Class 2 Device Recall Synthesis

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  Class 2 Device Recall Synthesis see related information
Date Initiated by Firm October 06, 2014
Date Posted December 29, 2014
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-0877-2015
Recall Event ID 69879
510(K)Number K110604  
Product Classification Syringe, balloon inflation - Product Code MAV
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
Code Information Batch numbers: 4041354/4062650/4072586
Recalling Firm/
Manufacturer		 PEROUSE MEDICAL
ROUTE DU MANOIR
Ivry Le Temple France
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAV and Original Applicant = SYNTHES
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