FDA Device recall Z-2445-2015
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells
- FDA Device
- Class II
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells by Omnilife Science, citing the device may have improper screw hole placement due to inaccurate location of the index line.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2445-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-04 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Omnilife Science |
| Distribution | US |
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.
Reason
The device may have improper screw hole placement due to inaccurate location of the index line.
Identifiers
| code_info | H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2445-2015%22
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