XTANT Medical Holdings, Inc: Medical Device Recall in 2025 - (Recall #: Z-1177-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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))

Product Classification:

Class II

Date Initiated: January 3, 2025

Date Posted: February 26, 2025

Recall Number: Z-1177-2025

Event ID: 96179

Reason for Recall:

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

Status: Ongoing

Product Quantity: 14 units

Code Information:

Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.

Voluntary or Mandated:

Voluntary: Firm initiated