Spinal Elements recalls AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumba…

Recall date

April 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1912-2018

FDA classification

Class II

Brand / firm

Spinal Elements

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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