{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197236", "product_res_number": "Z-0738-2023", "event_date_initiated": "2022-11-10", "event_date_posted": "2022-12-20", "recall_status": "Open, Classified", "res_event_number": "91196", "product_code": "MQP", "k_numbers": [ "K090176" ], "product_description": "X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.", "code_info": "Part Numbers / UDI-DI Code:\n7160012 /887517424204,\nLot Numbers:\nEM3755\nEM3755\nEM3755\nEM3761\nEM5349\nEM5349\nEM5349\nEM6061\nNN1674\nNN2646\nNN1674\nNN2646\nNN3352\nPD0066\nNN3352\nPD0515\nPD0066\nPD0515\n\n7160014 / 887517424211,\nLot Numbers:\nEM3756\nEM3756\nEM3756\nEM3756\nEM3762\nEM5351\nEM6064\nEM6062\nEM6063\nNN1902\nNN3350\nNN1902\nNN3350\nPD0392\nPD0805\nPD0805\nPD0392\n\n7180016 / 887517426277,\nLot Numbers:\nEM3763\nEM3757\nEM3757\nEM3757\nEM5353\nEM5352\nEM6068\nEM6067\nEM6066\nEM6065\nDR6677\nDR6677\nDR6901\nDR6958\nDR7357\nDR7357\nDR8110\nDR8465\nDR8897\nDR9443\nDR7357\nDR9592\nDR9592\nDR9443\nDR9592\nDR9592\nNN1445\nNN1445\nNN1446\nNN1451\nNN1445\nNN1473\nNN1473\nNN3294\nNN3294\nPD0146\nPD0146\nPD0706\n\n7180018 / 887517426284,\nLot Numbers:\nEM3758\nEM3764\nEM5354\nEM5354\nEM6070\nEM6069\nDR6624\nDR6658\nDR6957\nDR6658\nDR7376\nDR8930\nNN0628\nNN0817\nNN1360\nDR7376\nDR7376\nNN1891\nNN1891\nNN1891\nNN2971\nNN2971\nNN3368\nNN3368\nPD0794\n\n7220016 / 887517434210,\nLot Numbers:\nEM3765\nEM3759\nEM6072\nEM6072\n\n7220018 / 887517434227\nLot Numbers:\nEM3760\nEM3766\nEM3760\nEM3760\nEM6073", "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": "Patrick Yrigoyen\n858-336-3421", "reason_for_recall": "Potential that insert will be unable to disengage from the vertebral body replacement device/implant", "root_cause_description": "Device Design", "action": "On 11/10/2022, the firm sent an \"URGENT FIELD SAFETY NOTICE\" Letter via email to customers informing them that the firm has received product complaints regarding difficulty in disengaging the Inserter from the X-Core, Static Core implant. NuVasive is updating the Instructions For Use (IFU) and Surgical Technique Guide (STG) to clarify the best fit inserter with each core which can help prevent the user experiencing interference when removing the inserter from the Static Core.\n\nRecommended User Actions:\n This FSN details updates to the IFU document that physicians should consult prior to and during patient care of those being treated with Static X-Core devices. This interference presents when attempting to engage or disengage the Static Core implant from the inserter.\n- The IFU and STG should be consulted on an ongoing basis before and throughout patient treatment.\n- A NuVasive representative will be contacting their office to help with any questions or concerns.\n- Acknowledgement of these changes is critical. Review, complete, sign and return the attached Consignee Confirmation Form in accordance with the directions on the form (accompanying this notification).\n\nUpdated IFU and STG Language:\nWhen assembling the construct with static cores, only utilize dismantlable inserters.\nWhen utilizing 16mm static cores, refer to the Surgical Technique for instructions on removing the internal gear drive from the appropriate dismantlable inserter.\nTo help achieve proper inserter/implant engagement, the inserter s colored distal tip must face up toward the like-colored spinning sleeve of the implant.\nTo help achieve proper anatomical alignment, the rounded corners of the X-Core shape endcaps must face anterior during implant construction and placement.\nCare should be taken to confirm that all components are ideally fixated prior to closure.", "product_quantity": "2,031 devices", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of NC, CA, FL, KY, IL, TX, CO, OH, AK, GA, UT, MA, WA, HI, AL, NY, WI, AR, ID, VA, PA, SC, MD, PA, AZ, RI, IN, ME, NJ, MI, TN, MN, OR, OK, WY, and Puerto Rico. 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