Omni Life Science: Medical Device Recall in 2012 - (Recall #: Z-2375-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.

Product Classification:

Class II

Date Initiated: August 9, 2012

Date Posted: September 19, 2012

Recall Number: Z-2375-2012

Event ID: 62912

Reason for Recall:

The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility

Status: Terminated

Product Quantity: 36 units

Code Information:

Lot Numbers: 10723, 10763, 10824

Distribution Pattern:

Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated