FDA Device recall Z-2064-2015
Apex ARC Hip Stem, HA Coated, Size 5
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of Apex ARC Hip Stem, HA Coated, Size 5 by Omnilife Science, citing product may breach the inner and outer sterile pouches during shipping or handling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2064-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-03 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Omnilife Science |
| Distribution | US |
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 titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
Reason
Product may breach the inner and outer sterile pouches during shipping or handling.
Identifiers
| code_info | Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070 |
|---|
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-2064-2015%22
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