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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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