XTANT Medical Holdings, Inc. is recalling 14 units of the Irix-A Integrated Lumbar Fusion System because certain spinal implants were distributed with incorrect expiration dates on their labels. This recall specifically affects spacer assemblies used in lumbar fusion surgeries (models X080-423011-08PC and X080-382819-08PC). No injuries or incidents have been reported in connection with this labeling error.
The incorrect expiration dates could result in surgeons using implants that are no longer sterile or whose material integrity has been compromised. This poses a potential risk of surgical site infections or device failure during or after implantation.
Correction of labeling or replacement of the device.
Incorrect expiration date labeling.
Incorrect expiration date labeling.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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