| | Class 2 Device Recall OneLIF Intervertebral Body Replacement System |  |
| Date Initiated by Firm | April 23, 2026 |
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| Date Posted | May 20, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2213-2026 |
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| Recall Event ID |
98835 |
| 510(K)Number | K211769 |
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| Product Classification |
Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
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| 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, |
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| Code Information |
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 |
| FEI Number |
3020307303
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Recalling Firm/
Manufacturer |
Novapproach Spine, LLC
13900 Tech City Cir Ste 300
Alachua FL 32615-6091
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| For Additional Information Contact |
386-588-3408 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Process design |
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| Action | On 4/23/2026, removal notices were sent to customers who were asked to do the following:
1) Return affected devices using the return label.
2) Firm is providing unaffected kits.
If you have recall-related questions contact firm at Ron.Green@NovApproachspine.com |
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| Quantity in Commerce | 1259 |
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| Distribution | US Nationwide distribution in the states of NY, CT, CA, TX, FL, MI. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OVD
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