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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
See all 3 products in this recall →Related recalls
Same manufacturer · OMNIlife science Inc.
See all →- SevereOMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation
FDA (Devices) · 2021-02-03
- HighOmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits
FDA (Devices) · 2021-02-03
- SevereOMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts
FDA (Devices) · 2021-02-03
- HighOMNI Hip System Femoral Component Recalled for Missing Porous Coating
FDA (Devices) · 2019-10-30
- HighOMNIlife 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
Similar recalls
- ModerateOMNI Hip System Acetabular Inserts Recalled for Improper Labeling
FDA (Devices) · 2018-08-01
- SevereOMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation
FDA (Devices) · 2021-02-03
- HighOmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits
FDA (Devices) · 2021-02-03
- SevereOMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts
FDA (Devices) · 2021-02-03
- HighFDA Recalls Omnilife Apex Interface Acetabular Shells Due to Design Defect
FDA (Devices) · 2015-09-02
- HighHip implant acetabular liners recalled for edge-loading and premature wear
FDA (Devices) · 2021-07-28