Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
This recall is currently active, issued July 12, 2024. It was issued by Med-El Elektromedizinische Gereate, Gmbh Furstenweg 77A Innsbruck Austria.
- Recall Initiated
- April 18, 2024
- Posted
- July 12, 2024
- Recall Number
- Z-2356-2024
- Quantity
- 7 devices
- Official Source
- View on FDA website ↗
Reason for Recall
A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
Distribution
US, Durham, NC
Lot / Code Info
a) 39541, UDI/DI 09008737395414, Serial Numbers: 859106; b) 39545, UDI/DI 09008737395452, Serial Numbers: 860731, 860782, 863380; c) 39547, UDI/DI 09008737395476, Serial Numbers: 860757, 860772, 863386
Root Cause
Nonconforming Material/Component
Action Taken
MED-EL issued an Urgent-Medical Device Field Safety Notice (FSN) Medical Device Return notice to its sole US consignee (distributor) on 04/18/2024 via email. The notice explained the problem with the device and requested the return of all affected devices.