Omni Life Science Apex Knee System Modular Tibia Augment Recall
Omni Life Science is recalling 182 units of the Apex Knee System Modular Tibia Augment because the sterile pouches may breach, compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a breach in sterile packaging compromises sterility, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Omni Life Science is recalling 182 units of the Apex Knee System Modular Tibia Augment, Size 5 x 4mm (Ref: KC-54050). The product is intended for use as a primary or revision total knee replacement. The recall is due to a defect where the inner and outer sterile pouches may breach, which compromises the sterility of the device.
The affected lot numbers are 8396, 8989, 9225, 10316, 10713, 11571, and 11669. The products were distributed worldwide, including nationwide in the United States (specifically Colorado, New York, Oklahoma, Pennsylvania, Utah, Virginia, and Wisconsin) and in Spain and the Netherlands.
Healthcare providers and patients should contact Omni Life Science for further instructions regarding the return or replacement of these devices.
The recalled product
- 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.
- Manufacturer
- Omni Life Science
- Affected units
- 182
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers: 8396
- 8989
- 9225
- 10316
- 10713
- 11571
- 11669
Distribution
Part of a larger recall action
This product is one of 6 recalled by Omni Life Science under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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- HighOmni Life Science Recalls Apex Knee System Modular Tibia Augments
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- SevereOmni Life Science Recalls Apex Knee System Modular Tibia Augments
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- HighOmni Life Science Recalls Apex Knee System Tibia Augments
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