Omni Life Science Recalls Apex Knee System Modular Tibia Augments
Omni Life Science is recalling 310 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising the device's sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). A breach in sterile packaging for an implantable medical device presents a significant risk of infection.
Plain-English summary
Omni Life Science is recalling 310 units of the Apex Knee System Modular Tibia Augment, Size 3 x 4mm (Ref: KC-54030). The Apex Knee System is intended for use as a primary or revision total knee replacement.
The recall is being issued 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 8363, 8715, 8864, 8876, 8982, 9007, 9013, 9123, 9168, and 10317.
The products 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. 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 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
- Manufacturer
- Omni Life Science
- Affected units
- 310
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 (10)
- Lot Numbers: 8363
- 8715
- 8864
- 8876
- 8982
- 9007
- 9013
- 9123
- 9168
- 10317
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.
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