Recall Z-1395-2017 ยท ISM Pylon, Post Surgical
MED-EL Elektromedizinische Gereate, Gmbh
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.
| Date | Mar 2, 2017 (initiated Oct 25, 2016) |
| Status | Terminated |
| Reason | Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.