Omni Life Science Recalls Apex Knee System Tibia Augments
Omni Life Science is recalling 312 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 high-risk medical device where a sterility breach poses a risk of harm (infection), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Omni Life Science is recalling 312 units of the Apex Knee System Modular Tibia Augment, Size 1 x 4mm (Ref: KC-54010). The product is intended for use as a primary or revision total knee replacement.
The recall was initiated because the modular tibia augment may breach the inner and outer sterile pouches, which compromises the sterility of the device. The affected lot numbers are 8361, 8525, 8894, 8930, 8975, 9167, 9169, 10220, 10313, 10717, and 11547.
The affected units were distributed worldwide, including nationwide in the United States (specifically in CO, NY, OK, PA, UT, VA, and WI) 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 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
- Manufacturer
- Omni Life Science
- Affected units
- 312
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 (11)
- Lot Numbers: 8361
- 8525
- 8894
- 8930
- 8975
- 9167
- 9169
- 10220
- 10313
- 10717
- 11547
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 Recalled for Sterility Breach
FDA (Devices) · 2012-09-19
- 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
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- LowApex Knee System Tibial Baseplate Recalled for Packaging Date Error
FDA (Devices) · 2018-03-28
- ModerateZimmer Biomet Recalls Vanguard 360 Knee Augments Due to Missing Bolt
FDA (Devices) · 2018-10-03
- HighZimmer NexGen Option Stemmed Tibia Recalled for Sterility Concerns
FDA (Devices) · 2016-03-23
- HighOxford Partial Knee System Recalled for Compromised Sterile Barrier
FDA (Devices) · 2023-02-01
- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
FDA (Devices) · 2013-07-17
- HighOmnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings
FDA (Devices) · 2015-09-02