Omnilife Science Apex Knee System Modular Tibia Augment — Class II medical device recall Z-2370-2012
Terminated recall by Omni Life Science, reported 2012-09-19, distributed nationwide. The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the st
| Recall number | Z-2370-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Omni Life Science, East Taunton, MA, United States |
| Recall initiated | 2012-08-09 |
| Classified | 2012-09-13 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2013-01-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, NL |
| Quantity | 312 units |
| Reason classes | sterility |
| Lot numbers | 10220, 10313, 10717, 11547, 8361, 8525, 8894, 8930, 8975, 9167, 9169 |
| Model numbers | KC-54010 |
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Reason for recall
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2370-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.