The FDA has posted 9 enforcement recalls of lumbar intervertebral fusion device with integrated fixation devices since 2025, none of them Class I (most serious). Most recent report: May 27, 2026.
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and…
Labeling contains claims that are not consistently present.
Failure of fusion system instruments in the field.
Failure of fusion system instruments in the field.
Potential for the gold unlock button to separate from the inserter.
Potential for the gold unlock button to separate from the inserter.
Potential for the gold unlock button to separate from the inserter.
Potential for the gold unlock button to separate from the inserter.
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Intervertebral Fusion Device With Integrated Fixation, Lumbar”). Informational only — verify against the FDA before acting.