NEURO ZTI
Brand(s)
Summary
Consult your health care professional if you have used any of the products and have health concerns.
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
|---|---|---|
NEURO ZTI CLA |
NZA03295 |
M80184 |
NEURO ZTI EVO |
More than 10 numbers, contact manufacturer. |
M80185 |
Issue
|
The Neurelec quality system has recently identified an increase in the number of neuro ZTI device explants and devices under surveillance to be explanted because of a loss of hermeticity. The rising trend of early failures compared to the baseline is the reason for this voluntary recall. Our investigations have shown that it relates to a manufacturing deviation affecting potentially 3,976 Neuro ZTI implants.
Recall start date: 2021-10-14 |
What you should do
Consult your health care professional if you have used any of the products and have health concerns.
Additional information
Details
|
NEURELEC 2720 CHEMIN SAINT BERNARD, VALLAURIS FRANCE |
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