Z-1912-2018Class II

AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM))...

Name: Z-1912-2018 AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM))...
Creator: Spinal Elements
Published: 2018-04-16
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2018-04-16 / Open, Classified / root cause: labeling and UDI

FDA source

Spinal Elements began a recall of 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... on 2018-04-16. FDA classified it as Class II and gives the reason as "Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1912-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-04-16
Posted: 2018-05-23
Recalling firm: Spinal Elements, Inc
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
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 19 units
Distribution: US Distribution to the states of : FL, GA, NC, PA and CO
Product codes and lots: Lot Number 140760

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1912-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1912-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-05-30	2018-05-23

Product code MAX

K150395Class IIOmega LIF SystemAmendia, Inc. / cleared 2015-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)