Spinal Elements Recalls Omega Lumbar Interbody Fusion Devices
Spinal Elements is recalling 19 Omega Lumbar Interbody Fusion Devices because they were assembled with components that do not match the labeled lordosis angle.
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, and the source text describes a manufacturing discrepancy (mismatched lordosis angle) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Spinal Elements is recalling 19 units of the AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11, Lot Number 140760. The recall was initiated because the implants were labeled as having 11 degrees of lordosis but were assembled using components manufactured with 4 degrees of lordosis.
The affected devices were distributed in the United States to the states of Florida, Georgia, North Carolina, Pennsylvania, and Colorado. The OmegaLIF device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease.
Patients who have received this specific device should contact their healthcare provider to discuss the recall and determine if any further action is necessary.
The recalled product
- Product
- AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at…
- Manufacturer
- Spinal Elements
- Affected units
- 19
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 Number 140760
Distribution
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