Omnilife Science Inc. recalls Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral com…

Recall date

June 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2064-2015

FDA classification

Class II

Brand / firm

Omnilife Science Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)