OMNI Hip System Acetabular Inserts Recalled for Improper Labeling
OMNIlife science Inc. is recalling 16 units of ApeX-LNK Acetabular Inserts due to improper labeling on internal packaging and patient labels.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is improper labeling with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.
Plain-English summary
OMNIlife science Inc. is recalling 16 units of the OMNI Hip System, specifically the ApeX-LNK Acetabular Inserts (0 degree, 4+mm offset). The affected product codes are H6-14436, H6-13928, and H6-14836. These medical devices are intended for primary or revision total hip replacement procedures.
The recall was initiated because the internal packaging, pouch, and patient labels are improperly labeled. The affected units are associated with lot numbers 29147, 29148, and 29778. The products were distributed nationwide in the United States, specifically in the states of Arizona, California, Colorado, Illinois, Florida, and Massachusetts.
Healthcare providers and patients should verify if they have received or used these specific product codes and lot numbers. If the devices have been implanted, patients should consult their healthcare provider for guidance regarding the labeling discrepancy. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for…
- Manufacturer
- OMNIlife science Inc.
- Hazard
- Affected units
- 16
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 (2)
- Lot Numbers - 29147
- 29148 & 29778
Distribution
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