Omnilife Science Inc.: Medical Device Recall in 2015 - (Recall #: Z-2445-2015)

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:

APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.

Product Classification:

Class II

Date Initiated: June 4, 2015

Date Posted: September 2, 2015

Recall Number: Z-2445-2015

Event ID: 71461

Reason for Recall:

The device may have improper screw hole placement due to inaccurate location of the index line.

Status: Terminated

Product Quantity: 112

Code Information:

H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097

Distribution Pattern:

US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.

Voluntary or Mandated:

Voluntary: Firm initiated