Spinal Elements: Medical Device Recall in 2018 - (Recall #: Z-1912-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 16, 2018

Date Posted: May 30, 2018

Recall Number: Z-1912-2018

Event ID: 79889

Reason for Recall:

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

Status: Ongoing

Product Quantity: 19 units

Code Information:

Lot Number 140760

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated