The Recall Desk
HighFDA (Devices)·Z-2370-2012·Announced 2012-09-19

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.

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 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
Category
Medical Device — Orthopedic Implant
Hazard
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

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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

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Same hazard · sterility compromise

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