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Terminated

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.

FDA Recall Z-1395-2017 · Posted 2017-03-02

Recalling FirmMED-EL Elektromedizinische Gereate, Gmbh
Recall StatusTerminated
Product CodeISM
Date Initiated2016-10-25
Date Terminated2017-04-04
Product Quantity538 units

Reason for Recall

Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

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

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