Novapproach Spine, Llc: 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/s...
Summary Novapproach Spine, LLC is recalling OneLIF Interbody Cage implants and related kits used in spine fusion surgery because the surgical inserter tool may fail to properly attach to the cages, potentially causing delays during surgery or requiring doctors to use a different implant. The affected devices were distributed nationwide, and this is classified as a Class II recall.
- Recalling firm
- Novapproach Spine, LLC
- 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, 13 Degree 10mm X 6mm, 010-113-1006-2/Small, 13 Degree, 10mm X 6mm - Oblique, 010-113-1208/Small 13 Degree 12mm X 8mm, 010-113-1410/Small 13 Degree 14mm X 10mm, 010-113-1612/Small 13 Degree 16mm X 12mm, 010-119-1407/19 Degree 14mm X 7mm, 010-119-1609/Small 19 Degree 16mm X 9mm, 010-119-1811/Small 19 Degree 18mm X 11mm,...
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-23
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of NY, CT, CA, TX, FL, MI.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/468dce56-c13d-43e6-976e-981e84789d14