Omni Life Science Apex Knee System Modular Tibia Augment Recalled for Sterility Breach
Omni Life Science is recalling 270 Apex Knee System Modular Tibia Augments because the sterile pouches 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 medical device where sterility is compromised, posing a risk of infection (high-risk hazard), but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Omni Life Science is recalling 270 units of the Apex Knee System Modular Tibia Augment, Size 4 x 4mm (Ref: KC-54040). The recall is due to a potential breach of the inner and outer sterile pouches, which compromises the sterility of the device. The Apex Knee System is intended for use as a primary or revision total knee replacement.
The affected units are distributed worldwide, including nationwide in the United States (specifically CO, NY, OK, PA, UT, VA, and WI) and in Spain and the Netherlands. The recall covers lot numbers 8395, 8823, 8929, 8969, 8984, 9166, 10319, 10740, and 11703.
Healthcare providers and patients should check their inventory and records for these specific lot numbers. If the device has not been implanted, it should be returned to Omni Life Science. If the device has been implanted, patients should contact their healthcare provider for guidance.
The recalled product
- Product
- Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
- Manufacturer
- Omni Life Science
- Affected units
- 270
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 (9)
- Lot Numbers: 8395
- 8823
- 8929
- 8969
- 8984
- 9166
- 10319
- 10740
- 11703
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
Same manufacturer · Omni Life Science
See all →- LowOMNIBotics Tracker Kit Recalled for Incorrect Lot Number Labeling
FDA (Devices) · 2016-11-23
- HighOmni Life Science Apex Knee System Modular Tibia Augment Recall
FDA (Devices) · 2012-09-19
- HighOmni Life Science Recalls Apex Knee System Modular Tibia Augments
FDA (Devices) · 2012-09-19
- SevereOmni Life Science Recalls Apex Knee System Modular Tibia Augments
FDA (Devices) · 2012-09-19
- HighOmni Life Science Recalls Apex Knee System Tibia Augments
FDA (Devices) · 2012-09-19
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