FDA Device recall Z-2372-2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030
- FDA Device
- Class II
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class II recall of Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030 by Omni Life Science, citing the Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2372-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-09 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Omni Life Science |
| Distribution | US |
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Reason
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Identifiers
| code_info | Lot Numbers: 8363, 8715, 8864, 8876, 8982, 9007, 9013, 9123, 9168, 10317 |
|---|
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-2372-2012%22
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