OMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation
OMNIlife science Inc. is recalling 2 units of SERF Novae Dual Mobility Cup Inserts because they have higher than acceptable oxidation limits, which 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 significant injury risk (revision surgery) due to a structural/material defect (oxidation), meeting the criteria for a Severe rating.
Plain-English summary
OMNIlife science Inc. is recalling 2 units of the SERF Novae Dual Mobility Cup Insert 49/28-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 28572, and the product code is H6-24928.
The recall was initiated 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 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
- Manufacturer
- OMNIlife science Inc.
- Affected units
- 2
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: 28572
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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