FDA Medical Device Recalls (openFDA)
Spinal Elements: 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
- Recall number
- Z-1912-2018
- Recalling firm
- Spinal Elements
- 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
- Status
- Open, Classified
- Initiated
- 2018-04-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
- 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
- 19 units
- Distribution
- US Distribution to the states of : FL, GA, NC, PA and CO
- Lot, serial or model codes
- Lot Number 140760
- 510(k) numbers
- ["K150395"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3007970248
- Firm city
- Marietta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28