Z-0920-2021Class II

SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular...

Name: Z-0920-2021 SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular...
Creator: OMNIlife science Inc.
Published: 2020-12-21
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2020-12-21 / Terminated

FDA source

OMNIlife science Inc. began a recall of SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures... on 2020-12-21. FDA classified it as Class II and gives the reason as "Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0920-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-21
Posted: 2021-01-26
Terminated: 2021-06-10
Recalling firm: Omni Life Science, Inc.
Product: SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
FDA root cause: Under Investigation by firm
Action: Omni Life Initial communication was sent by email via a quarantine form on 12/09/2020. On 12/22/20 a notification packet detailing parameters of recall sent via email and overnight mail. Acknowledgement of receipt is requested. Actions to be taken by the Customer/User " Immediately quarantine lots 28413, 28624 and 28572 " Return Product to OMNI at 480 Paramount Drive, Raynham MA 02767 " This advisory notice only includes the lots identified above. It does not affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form by FAX to 508-819-3390 or my email to [email protected].
Quantity in commerce: 3 units
Distribution: AL, ID, MD, NY, OK
Product codes and lots: Lot Number: 28413

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0920-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0920-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-26
Z-0921-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-26
Z-0922-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-26

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)