Device product

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Z-0966-2025

November 24, 2024

Class II

Product summary

Firm: Adept Medical Ltd
Event: Event 95942
Status: Ongoing
Classification: Class II
Quantity: 6,280 units (2500 US, 3780 OUS)
Official record key: device-enforcement:Z-0966-2025

Official wording

Reason: Lack of 510(k) clearance.

Code information: Product Code: NZ3309; UDI-DI: 09421901970369; Lots: 2008-1459; 2009-1864; 2011-2331, 2012-2961, 2013-3122, 2013-3363, 2014-3783, 2014-3832, 2015-3943, 2016-4601, 2016-5197, 2017-5651, 2017-6150, 2018-6487, 2018-6818, 2019-7211, 2021-10033, 2022-10783, 2023-11053,

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
reason.no_named_rule · v1.0.0

Lack of 510(k) clearance.