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Health Canada Medical devices

NEURO ZTI

Issued November 12, 2021
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
Hazard description
Premature failure
What to do
​​​​​​​ Consult your health care professional if you have used any of the products and have health concerns.
Product
Product name
NEURO ZTI
Reference
ID
RA-63588