# FDA recall Z-1912-2018

> **Spinal Elements** · Class II · device recall initiated 2018-04-16.

## 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 preferences

## Reason for recall

Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.

## Distribution

US Distribution to the states of : FL, GA, NC, PA and CO

## Key facts

- **Recall number:** Z-1912-2018
- **Recalling firm:** Spinal Elements
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-04-16
- **Report date:** 2018-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1912-2018

## Citation

> AI Analytics. FDA recall Z-1912-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1912-2018. Source: US FDA. Licensed CC0.

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