OMNI Hip System Femoral Component Recalled for Missing Porous Coating
OMNIlife science Inc. is recalling three OMNI Hip System femoral components because they are missing the required porous coating.
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 3/5 (High).
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 structural defect in a medical device (missing porous coating) which is a risk-of-harm product, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
OMNIlife science Inc. is recalling three units of the OMNI Hip System, model HC-00070, which are intended for use as the femoral component of a primary or revision total hip replacement. The recall is due to a manufacturing defect where the stems are missing the porous coating on the device.
The affected units are from Lot # 33035. The distribution pattern indicates that these devices were shipped to Oklahoma and Illinois. No specific dates or additional distribution details are provided in the source text.
Consumers and healthcare providers who have these specific devices should contact OMNIlife science Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
- Manufacturer
- OMNIlife science Inc.
- Affected units
- 3
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 # 33035
Distribution
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