Z-2356-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2024
- Initiation Date
- April 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 devices
Product Description
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
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 Pattern
US, Durham, NC
Code Information
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