Device product
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Z-0965-2025
Product summary
- Event
- Event 95942
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,610 units (240 US, 2370 OUS)
- Official record key
device-enforcement:Z-0965-2025
Official wording
Reason: Lack of 510(k) clearance.
Code information: Product Code: NZ3309-2; UDI-DI: 09421901970376; Lots: 2009-1822, 2012-2723, 2013-3079, 2014-3452, 2014-3506, 2015-4277, 2016-4527, 2016-4664, 2016-4997, 2016-4997, 2017-5441, 2017-5674, 2017-6117, 2018-6458, 2018-6896, 2020-9591.
Distribution pattern: US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.
Derived failure modes
-
Unknown
Lack of 510(k) clearance.