Novapproach Spine, LLC recalls OneLIF Interbody Cage

Recalling company

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, 010-125-1606/Small 25 Degree 16mm X 6mm, 010-125-1808/Small 25 Degree 18mm X 8mm, 010-207-1007/Medium 7 Degree 10mm X 7mm, 010-207-1007-2/Medium 7 Degree 10mm X 7mm - Oblique, 010-207-1209/Medium 7 Degree 12mm X 9mm, 010-207-1411/Medium 7 Degree 14mm X 11mm, 010-207-1613/Medium 7 Degree 16mm X 13mm, 010-213-1206/Medium 13 Degree 12mm X 6mm, 010-213-1408/Medium 13 Degree 14mm X 8mm, 010-213-1610/Medium 13 Degree 16mm X 10mm, 010-213-1812/Medium 13 Degree 18mm X 12mm, 010-219-1406/Medium 19 Degree 14mm X 6mm, 010-219-1608/Medium 19 Degree 16mm X 8mm, 010-219-1810/Medium 19 Degree 18mm X 10mm, 010-225-1807/Medium 25 Degree 18mm X 7mm, 010-225-2009/Medium 25 Degree 20mm X 9mm, 010-307-1006/Large 7 Degree,10mm X 6mm, 010-307-1006-2/Large 7 Degree 10mm X 6mm - Oblique, 010-307-1208/ Large 7 Degree 12mm X 8mm, 010-307-1410/Large 7 Degree 14mm X 10mm, 010-307-1612/Large 7 Degree 16mm X 12mm, 010-313-1205/Large 13 Degree 12mm X 5mm, 010-313-1407/Large 13 Degree 14mm X 7mm, 010-313-1609/Large 13 Degree 16mm X 9mm, 010-313-1811/Large 13 Degree 18mm X 11mm, 010-313-2013/Large 13 Degree 20mm X 13mm, 010-319-1606/Large 19 Degree 16mm X 6mm, 010-319-1808/ Large 19 Degree 18mm X 8mm, 010-319-2010/ Large 19 Degree 20mm X 10mm, 010-325-2007/Large 25 Degree 20mm X 7mm, 010-325-2209/ Large 25 Degree 22mm X 9mm, Implant Kits containing OneLIF Interbody Cages, Name/Kit Family: Kit-OneLIF-10 mm (716)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (717)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (718)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (719)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (722)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (723)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (724)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (733)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (734)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (737)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (738)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (746)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (751)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (761)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (762)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (787)/Kit-OneLIF-10 mm, Kit-OneLIF- IMPOneLIF Implant Kit (701)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (702)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (703) NL/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (704)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (705)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (706)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (708)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (709)/Kit-OneLIF-IMP - OneLIF Implant Kit,

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 – may cause temporary or medically reversible health consequences

Recall date

Apr 23, 2026

Reported

May 27, 2026

Distribution

US Nationwide distribution in the states of NY, CT, CA, TX, FL, MI.

Status

Ongoing

Quantity

1259

Lot / codes

REF/UDI-DI/ Cage Lots: 010-107-1007/G07001010710070/ 103003, 105701, 118001, 129301; 010-107-1007-2/G070010107100720/ 114301, 117509, 128703; 010-107-1209/G07001010712090/ 102714, 105702, 117501; 010-107-1411/G07001010714110/ 103019, 105703; 010-107-1613/G07001010716130/ 103020, 105704, 127701; 010-113-1006/G07001011310060/ 103021, 105705, 118002, 129801; 010-113-1006-2/G070010113100620/ 117510, 127716, 114302; 010-113-1208/G07001011312080/ 103022, 105706, 117502, 126902; 010-113-1410/G07001011314100/ 102715, 105707, 127702; 010-113-1612/G07001011316120/ 103023, 105708, 127703; 010-119-1407/G07001011914070/ 103024, 105709, 125101, 128701; 010-119-1609/G07001011916090/ 102716, 105710, 127001; 010-119-1811/G07001011918110/ 103025, 105711, 127003; 010-125-1606/G07001012516060/ 102717, 117901, 127002; 010-125-1808/G07001012518080/ 103005, 117902, 127704; 010-207-1007/G07001020710070/ 102702, 106201, 118003, 125102; 010-207-1007-2/G070010207100720/ 117511, 124106, 127717, 114303; 010-207-1209/G07001020712090/ 102701, 105401, 124101, 127705, 101201; 010-207-1411/G07001020714110/ 105001, 105402, 101203; 010-207-1613/G07001020716130/ 103007, 105403, 124102, 127706; 010-213-1206/G07001021312060/ 105002, 105404, 121202, 124103, 127707, 101204; 010-213-1408/G07001021314080/ 102704, 105405, 121203, 124104, 127708; 010-213-1610/G07001021316100/ 103008, 105406, 130101; 010-213-1812/G07001021318120/ 103009, 105407, 127709; 010-219-1406/G07001021914060/ 102705, 105408, 117503, 119301, 121201

Company location

Alachua, FL

Recall type

Voluntary: Firm initiated

Recall number

Z-2213-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2213-2026 in the FDA Enforcement Report. Also see FDA recall press releases.