Reported Feb 26, 2025 · Ongoing
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE))…
XTANT Medical Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: XTANT Medical Holdings, Inc · 664 Cruiser Ln · Belgrade, MT · 59714-9719
Is this the product you have?
- 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))
- Lot codes and dates
- Model X080-382819-08PC-STR
UDI-DI M697X08038281908PCSTR1Lot Number 054961
- Model Number X080-423011-08PC-STR
UDI-DI: M697X08042301108PCSTR1Lot Number 053028
- Model X080-382819-08PC-STR
- Amount recalled
- 14 units
Where it was sold
Why it was recalled
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
This product could cause temporary or reversible health problems — stop using it.
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