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U.S. Department of Health and Human Services

Class 2 Device Recall SONNET

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  Class 2 Device Recall SONNET see related information
Date Initiated by Firm October 25, 2016
Date Posted March 02, 2017
Recall Status1 Terminated 3 on April 04, 2017
Recall Number Z-1395-2017
Recall Event ID 76503
PMA Number P000025S087 
Product Classification Pylon, post surgical - Product Code ISM
Product SONNET Mini Battery Pack CableProduct Usage:
The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.
Code Information Part No. 32291, Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50); Part No. 32292, Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50); Part No. 32293, Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50); Part No. 32294, Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50); Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and Part No. 32296, Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50). 
Recalling Firm/
Manufacturer		 MED-EL Elektromedizinische Gereate, Gmbh
Furstenweg 77a
Innsbruck Austria
Manufacturer Reason
for Recall		 Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.
FDA Determined
Cause 2		 Device Design
Action MED-EL is notifying all consignees to whom affected products have been directly shipped by Headquarters (based on first delivery shipment records) on 10/25/2016.
Quantity in Commerce 538 units
Distribution Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.
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.
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