Device recall
Z-2445-2015: APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model…
FDA device recall · Class II · Omnilife Science Inc.
Key facts
| Recall number (Z-number) | Z-2445-2015 |
|---|---|
| Recall event | 71461 |
| Product | APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. |
| Product code | LPH |
| Recalling firm | Omnilife Science Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2015 |
| 510(k) numbers | K112779 |
| 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