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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