Device recall
Z-1107-2010: ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8…
FDA device recall · Class II · Stryker Instruments Div. of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1107-2010 |
|---|---|
| Recall event | 54622 |
| Product | ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8, Stryker Instruments, Kalamazoo, MI. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It… |
| Product code | GDY |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2010 |
| 510(k) numbers | K9410605 |
| FEI number | 1811755 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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