Device recall
Z-1973-2010: TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile…
FDA device recall · Class II · KARDIUM INC.
Key facts
| Recall number (Z-number) | Z-1973-2010 |
|---|---|
| Recall event | 55419 |
| Product | TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical sutures for sternal closure. The device should not be used on patients with poor… |
| Product code | HXS |
| Recalling firm | KARDIUM INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2010 |
| FEI number | 3007603855 |
At a glance
- None 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