Device recall
Z-0797-2010: MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE…
FDA device recall · Class I · Gyrus ACMI Corporation
Key facts
| Recall number (Z-number) | Z-0797-2010 |
|---|---|
| Recall event | 54356 |
| Product | MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear. |
| Product code | ETD |
| Recalling firm | Gyrus ACMI Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 27, 2010 |
| 510(k) numbers | K820362 |
| FEI number | 3003790304 |
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