Z-2480-2019Class II

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner...

Name: Z-2480-2019 OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner...
Creator: OMNIlife science Inc.
Published: 2019-07-23
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2019-07-23 / Terminated / root cause: manufacturing process

FDA source

OMNIlife science Inc. began a recall of OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128 on 2019-07-23. FDA classified it as Class II and gives the reason as "Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery". 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-2480-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-23
Posted: 2019-09-05
Terminated: 2020-04-24
Recalling firm: Omni Life Science, Inc.
Product: OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: OMNIlife science, Inc. sent an Urgent Medical Device Recall letter, dated July 23rd, 2019. 1. Identify the affected product from inventory and hold (quarantine) the product. 2. Return product to Omni at 480 paramount drive, Raynham, MA 02767 3. Acknowledge this notice by retuning the acknowledgement and receipt form by fax to 508-819-3390 or email to [email protected] For further information contact Christina Rovaldi, Regulatory Affairs Manager at 774-226-1847 or 800-448-6664. Return the attached Acknowledgement form by FAX to 508-819-3390 or by email to [email protected]. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Quantity in commerce: 22 units
Distribution: US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
Product codes and lots: LOT # 31740

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2480-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2479-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2480-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2481-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05

Product code LZO

K111572Class IINovae Sunfit Th Dual Mobility Acetabular Cup Model Sunfit Th (Metal-Back), Novae E Th Dual Mobility Acetabular Cup ModelSerf / cleared 2011-08-29

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)