Device recall
Z-1066-2013: Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers…
FDA device recall · Class II · Stelkast Co
Key facts
| Recall number (Z-number) | Z-1066-2013 |
|---|---|
| Recall event | 64505 |
| Product | Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip. |
| Product code | OQG |
| Recalling firm | Stelkast Co |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2014 |
| 510(k) numbers | K122773 |
| FEI number | 3004142400 |
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