Device recall
Z-2064-2015: Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage…
FDA device recall · Class II · Omnilife Science Inc.
Key facts
| Recall number (Z-number) | Z-2064-2015 |
|---|---|
| Recall event | 71407 |
| Product | Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from… |
| Product code | LZO |
| Recalling firm | Omnilife Science Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2015 |
| 510(k) numbers | K090845 |
| FEI number | 3008342029 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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