OMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts
OMNIlife Science Inc. is recalling 3 units of SERF Novae Dual Mobility Cup Inserts due to high oxidation levels that may increase wear rates and require revision surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a defect that may require revision surgery, which aligns with the rubric criteria for Severe severity involving significant injury or hospitalization reports.
Plain-English summary
OMNIlife Science Inc. is recalling 3 units of the SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. These medical devices are intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. The specific lot number is 28624.
The recall is being issued because the acetabular liners have a higher than acceptable oxidation limit. This defect creates a potential for patients to experience a higher wear rate for the acetabular liners, which may require a revision surgery.
The affected units were distributed in Alabama, Idaho, Maryland, New York, and Oklahoma. Patients who have had this specific device implanted should contact their healthcare provider for evaluation and guidance.
The recalled product
- Product
- SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
- Manufacturer
- OMNIlife science Inc.
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 28624
Distribution
Part of a larger recall action
This product is one of 3 recalled by OMNIlife science Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · OMNIlife science Inc.
See all →- HighOmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits
FDA (Devices) · 2021-02-03
- SevereOMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation
FDA (Devices) · 2021-02-03
- HighOMNI Hip System Femoral Component Recalled for Missing Porous Coating
FDA (Devices) · 2019-10-30
- HighOMNIlife ApeX Acetabular Liner Recalled for Oxidation Testing Failure
FDA (Devices) · 2019-09-11
- HighOMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure
FDA (Devices) · 2019-09-11
Same hazard · oxidation
See all →- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
- ModerateIcosapent Ethyl Capsules Recalled for Failed Tablet Specifications
FDA (Drugs) · 2025-06-18
- ModerateExactech Shoulder Implant Components Recalled for Nonconforming Oxygen Barrier Packaging
FDA (Devices) · 2024-04-10
- HighKnee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk
FDA (Devices) · 2024-02-07
- HighKnee implant component recalled due to potential material oxidation
FDA (Devices) · 2024-02-07