OneLIF Interbody Cage
The OneLIF Interbody Cage's inserter may fail to attach, causing procedural delays.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Novapproach Spine, LLC of Alachua, Florida, recalled the OneLIF Interbody Cage because the 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, leading to procedural delay and/or the need to select an alternative implant.
The recall began April 23, 2026, and was added to the FDA's Enforcement Report on May 20, 2026, with distribution in California, Connecticut, Florida, Michigan, New York, and Texas.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code is listed.
OneLIF Interbody Cage (REF/Description)
- Lot
- 010-107-1007
- G07001010710070
- 103003
- 105701
- 118001
- 129301
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of New York, Connecticut, California, Texas, Florida, Michigan.
- Event ID
- 98835
- Recall No.
- Z-2213-2026
- Company
- Novapproach Spine, LLCAlachua, Florida
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
