Notice names this product. Novapproach Spine’s OneLIF Interbody Cage (REF/Description) is named in FDA Class II recall Z-2213-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: 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, 124105; 010-219-1608/G07001021916080/ 103010, 105409, 121204, 127710; 010-219-1810/G07001021918100/ 103011, 105410, 127711; 010-225-1807/G07001022518070/ 102706, 113701, 117001, 121205; 010-225-2009/G07001022520090/ 103001, 117903, 127004, 127712; 010-307-1006/G07001030710060/ 102707, 106202, 118004, 129302; 010-307-1006-2/G070010307100620/ 117512, 127718, 114304; 010-307-1208/G07001030712080/ 102709, 105601, 117504; 010-307-1410/G07001030714100/ 102710, 105602, 127713; 010-307-1612/G07001030716120/ 103012, 105603, 117505; 010-313-1205/G07001031312050/ 103013, 105604, 117506, 129303; 010-313-1407/G07001031314070/ 102711, 105605, 117507, 124107, 128702, 130102; 010-313-1609/G07001031316090/ 103014, 105606; 010-313-1811/G07001031318110/ 103015, 105607, 127714; 010-313-2013/G07001031320130/ 103016, 105608, 127715; 010-319-1606/G07001031916060/ 102712, 105609, 114905, 117508; 010-319-1808/G07001031918080/ 103017, 105610, 125103; 010-319-2010/G07001031920100/ 103018, 105611, 125104; 010-325-2007/G07001032520070/ 102713, 105612, 121206; 010-325-2209/G07001032522090/ 105613, 121207, 101206, 101207, 101208. Units affected: 1,259. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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,
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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, …
Company / brand: Novapproach Spine recalls
Affected product: OneLIF Interbody Cage (REF/Description) recall status
Official ID Z-2213-2026 · Official record ↗
See all Novapproach Spine recalls →
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.