OMNIlife science Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
OMNIlife science Inc.
Lot Codes / Batch Numbers
Lot Number: 28413
Products Sold
Lot Number: 28413
OMNIlife science Inc. is recalling SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modul due to Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and req. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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 Omni-cs@coringroup.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, ID, MD, NY, OK
Page updated: Jan 10, 2026