OMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure
OMNIlife science Inc. is recalling six ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to 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 medical device defect that may lead to revision surgery, meeting the criteria for a Severe rating.
Plain-English summary
OMNIlife science Inc. is recalling six units of the ApeX acetabular liner, a hip prosthesis component. The specific product is the ApeX-LNK crosslinked Acetabular Insert with a 10-degree hood, identified by Product Code H5-54840 and Lot # 31707.
The recall was initiated because the acetabular liners failed oxidation testing performed prior to release. This failure 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 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 component implanted should contact their healthcare provider to discuss the potential risks and necessary follow-up care.
The recalled product
- Product
- OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
- Manufacturer
- OMNIlife science Inc.
- Affected units
- 6
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 # 31707
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.
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Same hazard · wear rate
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