Irix-A Lumbar Fusion Implants Recalled for Incorrect Expiration Dates
XTANT Medical Holdings is recalling Irix-A Lumbar Fusion System implants due to incorrect expiration date labeling on sterile spacers. Fourteen units were distributed in Arizona, California, Colorado, Louisiana, Ohio, Texas, West Virginia, and Australia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving sterile medical implants with incorrect expiration date labeling, constituting a risk-of-harm product. No illnesses, injuries, or hospitalizations have been reported, keeping the score at 3 per the rubric criteria.
Plain-English summary
XTANT Medical Holdings, Inc. is recalling certain implants in the Irix-A Lumbar Fusion System due to incorrect expiration date labeling during distribution. The recalled models are spacer assemblies: Model X080-423011-08PC (Lot 053028) and Model X080-382819-08PC (Lot 054961).
Fourteen units of these sterile spinal fusion spacers were affected. The implants were distributed in Arizona, California, Colorado, Louisiana, Ohio, Texas, West Virginia, and Australia.
No illnesses or injuries have been reported in connection with this labeling issue.
The recalled product
- 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 X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
- Manufacturer
- XTANT Medical Holdings, Inc
- Hazard
- incorrect-expiration-date
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1
- Lot Number 054961
- Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1
- Lot Number 053028
Distribution
Distributed nationwide across the United States.
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