Device product

Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

Z-0963-2025

November 24, 2024

Class II

Product summary

Firm: Adept Medical Ltd
Event: Event 95942
Status: Ongoing
Classification: Class II
Quantity: 13,070 units (9090 US, 3980 OUS)
Official record key: device-enforcement:Z-0963-2025

Official wording

Reason: Lack of 510(k) clearance.

Code information: Product Code: NZ3306; UDI-DI: 09421901970345 (NZ3306); Lots: 2008-1457, 2008-1525, 2009-1845, 2010-2037, 2011-2486, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2013-3120, 2013-3221, 2014-3428, 2014-3519, 2014-3615, 2015-4103, 2016-4599, 2016-5195, 2017-5591, 2017-5812, 2018-6393, 2019-7042, 2019-9076, 2020-9292, 2020-9476, 2022-10874, 2023-11128, 2023-11542,

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.