OMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure
OMNIlife science Inc. is recalling 22 ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.
What this means for you
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 is classified as FDA Class II, and the hazard involves a risk of harm (revision surgery) where no specific injuries or illnesses have been reported yet, fitting the criteria for a High severity score.
Plain-English summary
OMNIlife science Inc. is recalling 22 units of the ApeX acetabular liner, a hip prosthesis component. The specific product is the Serf Dual Mobility Cup Insert Liner 51-28, identified by product code H6-25128 and lot number 31740.
The recall was initiated because the acetabular liners failed oxidation testing performed prior to release. This defect may result in a higher wear rate for the component, which could lead to the need for revision surgery.
The affected units were distributed nationwide to Illinois, New York, Oklahoma, Maryland, Alabama, Pennsylvania, Colorado, Florida, and Utah. Patients who have had this specific hip prosthesis component implanted should contact their healthcare provider to discuss the recall and determine if any action is necessary.
The recalled product
- Product
- OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
- Manufacturer
- OMNIlife science Inc.
- Affected units
- 22
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 # 31740
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.
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FDA (Devices) · 2021-02-03
- SevereOMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation
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- HighOmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits
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- HighOMNI Hip System Femoral Component Recalled for Missing Porous Coating
FDA (Devices) · 2019-10-30
- SevereOMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure
FDA (Devices) · 2019-09-11
Same hazard · wear rate
See all →- HighOMNIlife ApeX Acetabular Liner Recalled for Oxidation Testing Failure
FDA (Devices) · 2019-09-11