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U.S. Department of Health and Human Services

Class 2 Device Recall Mi1250 SYNCHRONY 2

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 Class 2 Device Recall Mi1250 SYNCHRONY 2see related information
Date Initiated by FirmApril 18, 2024
Date PostedJuly 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2356-2024
Recall Event ID 94531
PMA NumberP000025 
Product Classification Implant, cochlear - Product Code MCM
ProductMi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
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
FEI Number 3000249315
Recalling Firm/
Manufacturer		 MED-EL Elektromedizinische Gereate, Gmbh
Furstenweg 77a
Innsbruck Austria
For Additional Information Contact
+43 577 88
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMED-EL issued an Urgent-Medical Device Field Safety Notice (FSN) Medical Device Return notice to its sole US consignee (distributor) on 04/18/2024 via email. The notice explained the problem with the device and requested the return of all affected devices.
Quantity in Commerce7 devices
DistributionUS, Durham, NC
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MCM
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