OmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits
OmnIlife Science is recalling three units of SERF Novae Dual Mobility Cup Inserts because they exceed acceptable oxidation limits, potentially increasing wear rates and the need for 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect (oxidation) poses a risk of harm (revision surgery), but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
OmnIlife Science Inc. is recalling three units of the SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. These medical devices are intended for use with the Apex Modular Acetabular Cup during total hip replacement procedures. The specific lot number is 28413, and the product code is H6-25128.
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 to discuss the potential risks and necessary follow-up care.
The recalled product
- 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
- 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: 28413
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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