Drugs & medicalClass II

XTANT Medical Holdings, Inc recalls Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model…

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

Read the official notice →
Date
2025-02-26
Country
United States
Brand
XTANT Medical Holdings
Product
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number…
Classification
Class II
Units
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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