Class II — Spinal Elements
| Recalling firm | Spinal Elements |
|---|---|
| Registered facility | SPINAL ELEMENTS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis. |
| 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 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 pre… |
| Quantity | 19 units |
| Distribution | US Distribution to the states of : FL, GA, NC, PA and CO |
| Initiated | 2018-04-16 |
| Classified | 2018-05-23 |
| Recall number | Z-1912-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spinal Elements (Z-1912-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79889/
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