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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
Recalled July 22, 2015 · FDA recall Z-2064-2015 · Omnilife Science
Hazard
Product may breach the inner and outer sterile pouches during shipping or handling. · FDA Class II
Units
146 devices
Sold at
US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
Description
Product may breach the inner and outer sterile pouches during shipping or handling.
Product
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)
Manufacturer(s)
Omnilife Science Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →