OMNIlife science Inc. OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
Brand
OMNIlife science Inc.
Lot Codes / Batch Numbers
LOT # 31706
Products Sold
LOT # 31706
OMNIlife science Inc. is recalling OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup due to Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Recommended Action
Per FDA guidance
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 Omni-cs@coringroup.com 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 Omnics@coringroup.com. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
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 noticePage updated: Jan 10, 2026