Device recall
Z-2308-2026: TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375…
FDA device recall · Class II · Grace Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2308-2026 |
|---|---|
| Recall event | 98773 |
| Product | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis |
| Product code | ETB |
| Recalling firm | Grace Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K060518 |
| FEI number | 1000022662 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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