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Synchrony 2 cochlear implant

Official notice

6 May 2024

Last checked

6 May 2024

Medium riskHealth Canada

An official Health Canada notice concerns Synchrony 2 cochlear implant. 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 Published 2024-05-06.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75484

Official notice

2024-05-06

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

75484

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Affected products

Product 1

Affected products - Mi1250 SYNCHRONY 2 Flex (26), Lot or serial number - Serial number 860791, Model or catalog number - 39575

Product 2

Affected products - Mi1250 SYNCHRONY 2 Flex (28), Lot or serial number - Serial number 863442 Serial number 859126, Model or catalog number - 39573

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Med-el Elektromedizinische Geraete, Synchrony 2 Cochlear Implant.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75484

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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