Recall Z-1177-2025— XTANT Medical Holdings, Inc

Name: FDA recall Z-1177-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-03

Class II · Ongoing

Class II FDA medical device recall by XTANT Medical Holdings, Inc, initiated 2025-01-03. It names one FDA 510(k) clearance: K171567. 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)). Reason: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date..

Recalling firm: XTANT Medical Holdings, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-01-03
Firm location: Belgrade, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K171567 — IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.·cleared 2017-08-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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))

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.