Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1912-2018 · Posted None

Recalling FirmSpinal Elements
Recall StatusOpen, Classified
Product CodeMAX
Date Initiated2018-04-16
Product Quantity19 units

Reason for Recall

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

Firm Action

The firm initiated the recall by letter on April 16, 2018, The firm requested return of the product. Distributors who further distributed the product were directed to notify their customers. For further questions, please call (760) 607-1812.

Root Cause

Labeling mix-ups

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑