Omnilife Science Inc.: Medical Device Recall in 2015 - (Recall #: Z-2454-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

Product Classification:

Class II

Date Initiated: June 9, 2015

Date Posted: September 2, 2015

Recall Number: Z-2454-2015

Event ID: 71470

Reason for Recall:

The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.

Status: Terminated

Product Quantity: 15

Code Information:

Lot Numbers: MM0314R, VA0713, Z1111

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated