Omnilife Apex Knee System Modular Tibia Augment Recalled for Sterility Breach
Omni Life Science is recalling 36 units of Apex Knee System Modular Tibia Augments because the sterile packaging may breach, compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (medical device) where sterility is compromised, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Omni Life Science is recalling 36 units of the Apex Knee System Modular Tibia Augment, Size 6 x 4mm (Ref: KC-54060). The affected lot numbers are 10723, 10763, and 10824. The Apex Knee System is intended for use as a primary or revision total knee replacement.
The recall is being conducted because the modular tibia augment may breach the inner and outer sterile pouches. This breach compromises the sterility of the device.
The affected units were distributed worldwide, including nationwide in the United States (specifically in Colorado, New York, Oklahoma, Pennsylvania, Utah, Virginia, and Wisconsin) and in Spain and the Netherlands. Consumers and healthcare providers should stop using the affected units and contact Omni Life Science for further instructions.
The recalled product
- Product
- Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
- Manufacturer
- Omni Life Science
- Affected units
- 36
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 (3)
- Lot Numbers: 10723
- 10763
- 10824
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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