Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AMENDIA Omega Lumbar Interbody Fusion Device Recalled by Spinal Elements Due to Omega LIF interbody implants labeled as having 11...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Spinal Elements directly.
Affected Products
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 one or two contiguous levels from L2-S1. The ¿LIF features a self-locking expansion mechanism that is infinitely adjustable, along with a bullet nose design for minimal impaction and ease of insertion. The ¿LIF is streamlined and available in various implant sizes to fit a variety of patient anatomies and surgical preferences
Quantity: 19 units
Why Was This Recalled?
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
Where Was This Sold?
This product was distributed to 5 states: CO, FL, GA, NC, PA
About Spinal Elements
Spinal Elements has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report