The Recall Desk
HighFDA (Devices)·Z-2373-2012·Announced 2012-09-19

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.

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 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
Category
Medical Device — Orthopedic Implant
Hazard
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

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 breach

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