Spinal Elements recalls OmegaLIF lumbar fusion devices with incorrect lordosis angle (4 degrees instead of 11) that could lead to improper spinal fusion. Affected patients should contact the company for details.
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
Spinal Elements is recalling OmegaLIF lumbar fusion implants that were assembled with 4 degrees of lordosis instead of the required 11 degrees. This mismatch could cause improper spinal fusion and potential complications after surgery.
The implant was designed to have 11 degrees of lordosis but was assembled using components with only 4 degrees. This incorrect angle could lead to improper spinal fusion, potentially causing pain, instability, or the need for additional surgery.
Patients who received the OmegaLIF lumbar fusion device with part number 72-00-2-092812-11 and lot number 140760 are affected. Surgeons who used this specific implant during spinal fusion procedures are most at risk.
Check for the part number 72-00-2-092812-11 and lot number 140760 on the device packaging or documentation. The device is used in spinal fusion procedures for degenerative disc disease.
Reach out to Spinal Elements directly for specific instructions on how to verify if your device is affected and what to do next.
The OmegaLIF implant was assembled with components that have 4 degrees of lordosis instead of the required 11 degrees, which could lead to improper spinal fusion.
Contact Spinal Elements directly to determine if your device is affected and follow their instructions.
The recall states that the incorrect lordosis angle could lead to improper spinal fusion, but the official notice does not specify if this causes serious injury in normal use.
We’ve drafted a message you can send Spinal Elements to request your refund or repair — edit it as you like.
Subject: Recall Z-1912-2018 — Spinal Elements Spinal Elements Hello, I own a Spinal Elements that is covered by recall Z-1912-2018 from Spinal Elements. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
