Device recall
Z-1978-2009: Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD Product Code…
FDA device recall · Class II · Omni Life Science
Key facts
| Recall number (Z-number) | Z-1978-2009 |
|---|---|
| Recall event | 52662 |
| Product | Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD Product Code: H3-82850. Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip. |
| Product code | KWY |
| Recalling firm | Omni Life Science |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2012 |
| 510(k) numbers | K082468 |
| FEI number | 3008342029 |
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