Z-2241-2014Class II

Apex Arc Hip Stem, Size 2, HA Coated

Name: Z-2241-2014 Apex Arc Hip Stem, Size 2, HA Coated
Creator: Omnilife Science Inc.
Published: 2014-05-09
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2014-05-09 / Terminated / root cause: manufacturing process

FDA source

Omnilife Science Inc. began a recall of Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA on 2014-05-09. FDA classified it as Class II and gives the reason as "Staining on hip implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2241-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-09
Posted: 2014-08-15
Terminated: 2014-08-19
Recalling firm: Omni Life Science, Inc.
Product: Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Staining on hip implant.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: All product was consigned to US sales Agents until implanted or returned to OMNI. All US Agents holding the inventory were notified on May9, 2014 by phone and follow up email that the product is being recalled. Customers have been instructed to immediately discontinue use and return the product to OMNIlife science.
Quantity in commerce: 13 devices
Distribution: US: CA, OK, VA, FL, MA, NY, TX
Product codes and lots: Lot: 17284

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2241-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2241-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15

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)