Device recall
Z-1568-2013: CMC Saddle Product Usage: The Ascension CMC is intended to resurface the…
FDA device recall · Class III · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1568-2013 |
|---|---|
| Recall event | 65362 |
| Product | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited… |
| Product code | KYI |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 8, 2014 |
| 510(k) numbers | K061451 |
| FEI number | 3003418325 |
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