Omni Life Science: Medical Device Recall in 2012 - (Recall #: Z-2370-2012)

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 1 x 4mm Ref: KC-54010. 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-2370-2012

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: 312 units

Code Information:

Lot Numbers: 8361, 8525, 8894,8930, 8975, 9167, 9169, 10220, 10313, 10717, 11547

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