Otological Ventilation Tube - T-Tube 6mm - Silicone recallZ-0963-2025 · Adept Medical Ltd · initiated Nov 24, 2024

Why it was recalled

Lack of 510(k) clearance.

FDA root cause category: Device Design

What the company is doing

On November 25, 2024 distributors were emailed URGENT MEDICAL ADVISORY RECALL NOTICES. We request that you please: 1. Complete the enclosed Recall Acknowledgement Form (even if you have no stock, please confirm via the No Stock tick box). 2. If you have stock, quarantine all stock of the above products. 3. Return the quarantined product to Adept Medical Ltd for credit processing as below. You should also check any stock held elsewhere in your organization. " If returning stock, please return stock with the completed Recall Acknowledgement Form to accompany the returned boxes. " Use our UPS account details as UPS :9F496F , postcode 2022 to process return freight " Send Completed Recall Acknowledgement Form to Yi Huang, Quality and Regulatory Manager, [email protected] and Viv So, Technical File Manager [email protected] We sincerely apologize for the inconvenience caused and assure you that the crediting of your returns will be treated as a matter of utmost urgency.

Recall details

Recall number

Z-0963-2025

Status

Open, Classified

Initiated by the company

Nov 24, 2024

Posted by the FDA

Jan 17, 2025

Recalling firm

Adept Medical Ltd

Quantity

13,070 units (9090 US, 3980 OUS)

Product code

ETD

FDA submissions

K061058

Distribution

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.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• NeoZoline NZ3306

  Adept Medical Limited · Tube, Tympanostomy
  1 recall0 reports

Other devices under the same FDA submission

7 devices cleared under K061058 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• NeoZoline NZ3306-2

  Adept Medical Limited · Tube, Tympanostomy
  1 recall0 reports
• NeoZoline NZ3309

  Adept Medical Limited · Tube, Tympanostomy
  1 recall0 reports
• NeoZoline NZ3309-2

  Adept Medical Limited · Tube, Tympanostomy
  1 recall0 reports
• NeoZoline NZ3312

  Adept Medical Limited · Tube, Tympanostomy
  1 recall0 reports
• NeoZoline NZ3312-2

  Adept Medical Limited · Tube, Tympanostomy
  1 recall0 reports
• NeoZoline NZ3321

  Adept Medical Limited · Tube, Tympanostomy
  1 recall0 reports
• NeoZoline NZ3321-2

  Adept Medical Limited · Tube, Tympanostomy
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 95942).

• Z-0964-2025 · Open, Classified
  Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
• Z-0965-2025 · Open, Classified
  Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
• Z-0966-2025 · Open, Classified
  Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
• Z-0967-2025 · Open, Classified
  Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
• Z-0968-2025 · Open, Classified
  Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
• Z-0969-2025 · Open, Classified
  Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
• Z-0970-2025 · Open, Classified
  Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;