Recall Z-2064-2015— Omnilife Science Inc.

Name: FDA recall Z-2064-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-03

Class II · Terminated

Class II FDA medical device recall by Omnilife Science Inc., initiated 2015-06-03, terminated 2015-09-08. It names one FDA 510(k) clearance: K090845. 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). Reason: Product may breach the inner and outer sterile pouches during shipping or handling..

Recalling firm: Omnilife Science Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Terminated: 2015-09-08
Firm location: East Taunton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K090845 — APEX ARC HIP STEMOmni Life Science, Inc.·cleared 2010-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.