The Recall Desk

Manufacturer

Novapproach Spine, LLC

2 recalls in our database name Novapproach Spine, LLC as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2026-05-27

Of the 2 recalls from Novapproach Spine, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Devices)·Z-2213-2026·2026-05-27

    OneLIF Interbody Cage Inserter Attachment Failure Recall

    Novapproach Spine is recalling OneLIF Interbody Cages because the straight inserter may fail to properly attach to the cages, potentially causing procedural delays or the need to use an alternative implant.

    Product
    OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2023·2022-11-23

    OneLIF Torque Limiting Adapter Recalled for Potential Locking Failure

    Novapproach Spine is recalling OneLIF Torque Limiting Adapter components used in spinal surgery instruments because the adapter may not remain locked in the ratcheting handle once fully engaged. This could compromise surgical instrument function during use.

    Product
    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
    Category
    Medical Device
    Distribution
    Distributed nationwide