NEWS/UPDATES OUTSIDE OF THE EEA/UK
Field Safety Notice, request by one EU authority to hold/investigate April 2022
Mycobacterial investigation ongoing, no growth/organisms found June 2022
Mycobacteria PCR and staining studies ongoing,
possible DNA could not yet be positively identified by Canadian labs July 2022
Field Safety Notice - Hold lifted for all territories outside of the EEA/UK July 2022
Field Safety Notice - Product update for countries outside of the EEA/UK -
no hold/restrictions, no bacterial culture growth, bacterial stains negative,
clinical events at normal/historical rates August 2022
NOTICE TO DISTRIBUTORS: No devices are to be shipped outside Jan 2023
your jurisdictions. There remain restrictions on devices in various countries,
particularly the EEA. While any holds on devices may be lifted in your home countries,
those devices are no cleared for shipment or sale to others.