The FDA has posted 9 enforcement recalls of lumbar intervertebral fusion device with bone graft devices since 2025, none of them Class I (most serious). Most recent report: Jan 21, 2026.
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury.…
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box.…
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative…
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Complaints have been received regarding post-operative implant collapse.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Intervertebral Fusion Device With Bone Graft, Lumbar”). Informational only — verify against the FDA before acting.