{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194600", "product_res_number": "Z-1453-2022", "event_date_initiated": "2022-06-20", "event_date_created": "2022-07-22", "recall_status": "Open, Classified", "res_event_number": "90500", "product_code": "MJO", "pma_numbers": [ "P200022" ], "product_description": "Description/Part: \nSimplify Disc Size 1, Ht 5/SM-5;\nSimplify Disc Size 1, Ht 6/SM-6;\nSimplify Disc Size 2, Ht 4/MD-4;\nSimplify Disc Size 2, Ht 5/MD-5;\nSimplify Disc Size 2, Ht 5, 5/MD-5L;\nSimplify Disc Size 2, Ht 6/MD-6;\nSimplify Disc Size 2, Ht 6, 5/MD-6L;\nSimplify Disc Size 3, Ht 5/LG-5;\nSimplify Disc Size 3, Ht 5, 5/LG-5L;\nSimplify Disc Size 3, Ht 6/LG-6;\nSimplify Disc Size 3, Ht 6, 5/LG-6L", "code_info": "Part/Correct GTIN (DI)/Lot:\nSM-5/843285100023/W79256, W82070, W80144;\nSM-6/843285100047/W80703, W81624, W80701, W81132, W81133, W81633, W81625, W81611, W81828, W81971, W82544, W82543, W81034, W81975, W81580, W81612, W81621, W81131, W81613, W80909, W81623, W81634, W79466, W81033, W81134, W81600, W79259;\nMD-5/843285100061/W81136, W81135, W80704, W80700;\nMD-5L/843285100078/W80707, W80706;\nMD-6/843285100085/W80911, W81642, W81643, W82545, W82546;\nMD-6L/843285100092/W81822;\nLG-5/843285100108/W81138, W81141, W79465, W81994, W81142, W81626, W81143, W79257;\nLG-5L/843285100115/W79258, W80146, W80915, W82548;\nLG-6/843285100122/W82547;\nLG-6L/843285100139/W81827", "firm_fei_number": "3002980729", "recalling_firm": "NuVasive Inc", "address_1": "7475 Lusk Blvd", "city": "San Diego", "state": "CA", "postal_code": "92121-5707", "additional_info_contact": "858-736-0318", "reason_for_recall": "Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.", "root_cause_description": "Labeling Change Control", "action": "On 06/20/22, Field Safety notices were delivered in person, emailed, or mailed to hospital and distributor consignees who were informed of the following:\n\n1) Complete and return the consignee confirmation form.\n2) Return of affected devices is not required. However, if you would like these items\nexchanged, please contact your firm representative to request a Return Material\nAuthorization number (RMA).\n3) This recall notice should be shared with anyone who needs to be aware within your\norganization or shared with any organization where the potentially affected products have been transferred.\n\nCustomers with questions, complaints, or who want to report adverse effects can contact the firm at complaints@nuvasive.com", "product_quantity": "1,963", "distribution_pattern": "US: CA, WA, TX, IN, MO, MI, FL, VA, OR.\n\nOUS: DE, NZ, SG, UK", "openfda": { "device_name": "Prosthesis, Intervertebral Disc", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "pma_number": [ "P060023", "P250042", "P110009", "P250028", "P100012", "P040006", "P070001", "P200022", "P110002", "P060018", "P100003", "P120024", "P170036", "P090029", "P050010" ], "registration_number": [ "3009888740", "3010057495", "1721676", "3007494564", "3011461101", "1824199", "8044172", "2031966", "3004188066", "1834331", "9615674", "3010178296", "3010120339", "3009973336", "3004774118", "3012447612", "1526534", "1649518", "3010120326", "3013055499", "2647346", "3007017524", "2219920", "3013491327", "3037407500", "3018094310", "3011277306", "2134285", "1221763", "3009417901", "2133928", "9611813", "3014213973", "3013944123", "3009144915", "2531195", "2183449", "1720929", "3010363503", "3004142400", "1423662", "2029275", "3003935342", "3006128100", "3025435185", "1319660", "3005144609", "3030412764", "1828464", "1030489", "3008812560", "3016438694", "1530390", "3003120897", "3010288357", "3004072627", "2032098", "3004788213", "3014252644", "3011521783", "3006001176", "3005061536", "3010120135", "1000200989", "1835251", "3015212339", "3005706667", "3010041430", "3030714745", "1833920", "9610612", "3024999441", "3016050940", "1424434", "3009973505", "8043792", "3007728266" ], "fei_number": [ "3009888740", "3010057495", "1721676", "3007494564", "3011461101", "1824199", "3002806653", "1000477302", "3004188066", "3000205591", "3002287318", "3003058448", "3010120339", "3009973336", "3012447612", "1526534", "3010120326", "3000215273", "3013055499", "2647346", "3001236277", "3007017524", "2219920", "3013491327", "3037407500", "3018094310", "3011277306", "1221763", "3009417901", "3002808269", "3014213973", "3013944123", "3009144915", "3000717902", "3002806685", "2183449", "1720929", "1000136478", "3010363503", "3002806315", "3004142400", "3000207350", "3003935342", "3006128100", "3000215103", "3025435185", "3002807479", "3005144609", "3030412764", "1828464", "3008812560", "3016438694", "1000306340", "3003120897", "3010288357", "3004072627", "3004788213", "1000306431", "3008599177", "3002795782", "3014252644", "1000115656", "3011521783", "3006001176", "3005061536", "3010120135", "1000200989", "3015212339", "3005706667", "3010041430", "3030714745", "3003110073", "3024999441", "3016050940", "3009973505", "3002980729", "3007728266" ] } } ] }