Z-2064-2015Class II

Apex ARC Hip Stem, HA Coated, Size 5

Name: Z-2064-2015 Apex ARC Hip Stem, HA Coated, Size 5
Creator: Omnilife Science Inc.
Published: 2015-06-03
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2015-06-03 / Terminated / root cause: packaging

FDA source

Omnilife Science Inc. began a recall of 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... on 2015-06-03. FDA classified it as Class II and gives the reason as "Product may breach the inner and outer sterile pouches during shipping or handling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2064-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Posted: 2015-07-14
Terminated: 2015-09-08
Recalling firm: Omni Life Science, Inc.
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)
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Product may breach the inner and outer sterile pouches during shipping or handling.
Root cause tag: packaging
FDA root cause: Packaging
Action: All product is consigned to US Agents until implanted or returned to OMNI. All US Agents holding the potentially affected inventory were notified that the product is being recalled via letter on June 3, 2015. The letter instructs them to immediately discontinue use of the product and contact OMNI Customer Service at 800-448-6664 to request a return materials authorization, and to return the Acknowledgement and Receipt form by FAX to 508-819-3390 or email to [email protected].
Quantity in commerce: 146 devices
Distribution: US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
Product codes and lots: Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2064-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2064-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-14

Product code LZO

K090845Class IIApex Arc Hip StemOmni Life Science, Inc. / cleared 2010-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)