Omnilife Science Inc.: Medical Device Recall in 2015 - (Recall #: Z-2064-2015)

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 ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)

Product Classification:

Class II

Date Initiated: June 3, 2015

Date Posted: July 22, 2015

Recall Number: Z-2064-2015

Event ID: 71407

Reason for Recall:

Product may breach the inner and outer sterile pouches during shipping or handling.

Status: Terminated

Product Quantity: 146 devices

Code Information:

Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070

Distribution Pattern:

US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.

Voluntary or Mandated:

Voluntary: Firm initiated