Health product recall

SYNCHRONY 2 Cochlear Implant

Last updated

Summary

Product
SYNCHRONY 2 Cochlear Implant
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalog number

Mi1250 SYNCHRONY 2 Flex (26)

Serial number 860791

39575

Mi1250 SYNCHRONY 2 Flex (28)

Serial number 863442
Serial number 859126

39573

Issue

MED-EL has recently identified a small number of devices, which may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device. MED-EL wants to avoid the implantation of any defective device and voluntarily request their immediate return from clinics and distributors.

Recall start date: April 19, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies

MED-EL Elektromedizinische Geraete GmbH

Fuerstenweg 77a, Innsbruck, Austria, 6020

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-75484

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