The Recall Desk
HighFDA (Devices)·Z-2371-2012·Announced 2012-09-19

Omni Life Science Recalls Apex Knee System Modular Tibia Augments

Omni Life Science is recalling 286 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 a breach in sterile packaging compromises sterility, posing a risk of infection or harm, but the source text does not report any specific illnesses or injuries.

Plain-English summary

Omni Life Science is recalling 286 units of the Apex Knee System Modular Tibia Augment, Size 2 x 4mm (Ref: KC-54020). The product is intended for use as a primary or revision total knee replacement. The recall is due to a defect where the inner and outer sterile pouches may breach, which compromises the sterility of the device.

The affected units were distributed worldwide, including nationwide in the United States (specifically Colorado, New York, Oklahoma, Pennsylvania, Utah, Virginia, and Wisconsin) and in Spain and the Netherlands. The recall covers specific lot numbers: 8362, 8524, 8853, 8988, 8992, 9021, 9040, 9152, 9883, 9885, 10221, 10318, 10726, and 11478.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products. Consumers who have had this specific implant should contact their healthcare provider for guidance.

The recalled product

Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. 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
286

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 (14)

  • Lot Numbers: 8362
  • 8524
  • 8853
  • 8988
  • 8992
  • 9021
  • 9040
  • 9152
  • 9883
  • 9885
  • 10221
  • 10318
  • 10726
  • 11478

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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