AMENDIA Omega Lumbar Interbody Fusion Device — Class II medical device recall Z-1912-2018
Ongoing recall by Spinal Elements, reported 2018-05-30, distributed in CO, FL, GA, NC, PA. Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactu
| Recall number | Z-1912-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spinal Elements, Marietta, GA, United States |
| Recall initiated | 2018-04-16 |
| Classified | 2018-05-23 |
| Reported by FDA | 2018-05-30 |
| Distributed | CO, FL, GA, NC, PA |
| Quantity | 19 units |
| Reason classes | labeling |
| Lot numbers | 140760 |
| Model numbers | 72-00-2-092812-11 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1912-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.