Device recall
Z-1731-2014: Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01…
FDA device recall · Class II · Summit Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1731-2014 |
|---|---|
| Recall event | 68267 |
| Product | Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane. |
| Product code | ETD |
| Recalling firm | Summit Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2014 |
| 510(k) numbers | K830228 |
| FEI number | 3008719017 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database