MED EL Cochlear Implant System recall
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO…
Why was MED EL Cochlear Implant System recalled?
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. Mil000 CONCERTO PIN +FLEX28, Serial Number 510312; b. Mi1000 CONCERTO +FLEX28, Serial Number 518214; c. Mi1000 CONCERTO PIN +FLEXsoft, Serial Number 531793; d. Mil000 CONCERTO +Standard, Serial Number 510079; e. Mil000 CONCERTO +Medium, Serial Number 532046; f. Mi1000 CONCERTO PIN +Standard, Serial Number 535616; g. M11000 CONCERTO +Compressed, Serial Number 538434
- Product
- MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO…
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Quantity
- 7 devices
- Distribution
- Worldwide distribution - US Nationwide in the states of California and Illinois. Countries of ARGENTINA, AUSTRALIA, AUSTRIA, BRAZIL, BULGARIA, CHINA, FRANCE, GEORGIA, KOREA, REPUBLIC OF, POLAND, RUSSIAN FEDERATION, SPAIN, SWEDEN.
- Recall date
- August 14, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)