Z-2445-2015Class II

APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356

Name: Z-2445-2015 APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356
Creator: Omnilife Science Inc.
Published: 2015-06-04
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2015-06-04 / Terminated / root cause: manufacturing process

FDA source

Omnilife Science Inc. began a recall of APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended... on 2015-06-04. FDA classified it as Class II and gives the reason as "The device may have improper screw hole placement due to inaccurate location of the index line". 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-2445-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Posted: 2015-08-21
Terminated: 2015-09-28
Recalling firm: Omni Life Science, Inc.
Product: APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The device may have improper screw hole placement due to inaccurate location of the index line.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Omni sent an Urgent Medical Device Field Correction letter dated June 4, 2015 via email to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory for affected product and complete and return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.
Quantity in commerce: 112
Distribution: US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
Product codes and lots: H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2445-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2445-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-21

Product code LPH

K112779Class IIApex Modular Acctabular Cup (Now Named Apex Interface Acetabular System)Omnlife Science / cleared 2011-12-02

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)