FDA recall Z-2356-2024

Product

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

US, Durham, NC

Key facts

Status

Ongoing

Initiation date

2024-04-18

Report date

2024-07-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Innsbruck, Austria

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2356-2024