🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: April 16, 2018 Spinal Elements Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot Number 140760
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Spinal Elements
Reason for Recall:
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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 Codes/Lot Numbers:

Lot Number 140760

Distribution:

Distributed in: US, FL, GA, NC, PA, CO

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1912-2018

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