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Invotec Nasal Septal Button
INVOTEC INTERNATIONAL, INC. · Model 001 · UDI-DI 00818501020003
1
510(k) clearances
7
Adverse events
2
Recalls
12
Facilities
Description
A device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-01-13 | Summit Medical, LLC | Sterile product pouches were not sealed. |
| 2010-03-15 | Micromedics, Inc. | Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product |
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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.