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Solo+ TTD Cartridge
AVENTAMED DESIGNATED ACTIVITY COMPANY · Model 12115-200-000 · UDI-DI 05391528890101
ETD
Prescription
1
510(k) clearances
92
Adverse events
14
Recalls
36
Facilities
Description
The Solo+ TTD is a single use, sterile, “all-in-one” surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-24 | Adept Medical Ltd | Lack of 510(k) clearance. |
| 2024-11-19 | Olympus Corporation of the Americas | Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ven |
| 2023-12-11 | Olympus Corporation of the Americas | The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.