Device recall
Z-0438-2011: The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog…
FDA device recall · Class II · Ascension Orthopedics, Inc
Key facts
| Recall number (Z-number) | Z-0438-2011 |
|---|---|
| Recall event | 56215 |
| Product | The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis for the basal thumb joint. The NuGrip is intended to replace the proximal end of the first metacarpal. |
| Product code | KYI |
| Recalling firm | Ascension Orthopedics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2011 |
| 510(k) numbers | K041451 |
| FEI number | 3002788818 |
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