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MEDICAL DEVICE RECALLMODERATE
OneLIF Interbody Cage
Novapproach Spine is recalling 60+ variants of OneLIF Interbody Cages due to a risk of inserter attachment failure during surgical procedures.
What to do
Healthcare providers should immediately stop using the affected OneLIF Interbody Cages and return all remaining inventory to the manufacturer.
Why it was recalled
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/or the need to select an alternative implant.
Where it was sold
Distributed in US.
Official source
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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification