Device recall
Z-0582-2015: Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for…
FDA device recall · Class II · Skeletal Dynamics
Key facts
| Recall number (Z-number) | Z-0582-2015 |
|---|---|
| Recall event | 69580 |
| Product | Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to… |
| Product code | KWI |
| Recalling firm | Skeletal Dynamics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2016 |
| 510(k) numbers | K092721 |
| FEI number | 3006742481 |
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