OMNIlife ApeX Acetabular Liner Recalled for Oxidation Testing Failure
OMNIlife science Inc. is recalling 14 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 involves a medical device defect that may lead to revision surgery, a significant health risk, but no injuries or illnesses have been reported in the source text.
Plain-English summary
OMNIlife science Inc. is recalling 14 units of the ApeX acetabular liner, a hip prosthesis component (Serf Dual Mobility Cup Liner 53-28, Product code: H6-25328). The specific lot number is 31706.
The recall was initiated because the acetabular liners failed oxidation testing performed prior to release. This defect may result in a higher wear rate, which could lead to the need for revision surgery.
The affected units were distributed nationwide in the United States to the states of 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 for evaluation.
The recalled product
- Product
- OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
- Manufacturer
- OMNIlife science Inc.
- Affected units
- 14
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 # 31706
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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- HighOMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure
FDA (Devices) · 2019-09-11
Same hazard · wear rate
See all →- SevereOMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure
FDA (Devices) · 2019-09-11