[Recalled] Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement. — The Apex Knee System Modular Tibia Augment may b
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement. |
|---|---|
| Brand / manufacturer | Omni Life Science |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2374-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 09 August 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Omni Life Science
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.