FDA-Device2015-07-22Class II
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)
Omnilife Science Inc.
Hazard
Product may breach the inner and outer sterile pouches during shipping or handling.
Sold states
US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
Affected count
146 devices
Manufactured in
50 Oconnell Way Ste 10, N/A, East Taunton, MA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2064-2015Don't want to check this manually?
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