{ "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": "2026-10-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "222236", "product_res_number": "Z-0137-2027", "event_date_initiated": "2026-08-12", "event_date_posted": "2026-10-09", "recall_status": "Open, Classified", "res_event_number": "99701", "product_code": "MBP", "k_numbers": [ "K042707", "K043048" ], "product_description": "Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue \ncombined with an inert additive to yield a demineralized bone matrix (DBM) \nallograft product having a particular physical form and/or handling property. \nGrafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form \nof DBM, while Grafton DBM Flex, Putty, Matrix, Crunch\" and Orthoblend are \nproduced from a fiber form of DBM Crunch\" also contains demineralized bone \nchips/cubes, while Grafton DBM Orthoblend contains non-demineralized \ncancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are \nmalleable and can be molded or cut into various sizes and shapes according to the \nintended implant site.", "code_info": "UDI-DI: 00643169123021. Serial Numbers: A62881-034 through A62881-051, specifically: \nA62881-034, A62881-035, A62881-036, A62881-037,\nA62881-038, A62881-039, A62881-040, A62881-041,\nA62881-042, A62881-043, A62881-044, A62881-045,\nA62881-046, A62881-047, A62881-048, A62881-049,\nA62881-050, A62881-051", "firm_fei_number": "1000477302", "recalling_firm": "Medtronic Sofamor Danek USA Inc", "address_1": "1800 Pyramid Pl", "city": "Memphis", "state": "TN", "postal_code": "38132-1703", "additional_info_contact": "Christine Stewart\n269-377-2557", "reason_for_recall": "Medtronic identified through donor record review that the donor for Medtronic \nbatch A62881 did not meet all Medtronic donor eligibility requirements related to \nthe presence of microbial organisms. While the batch passed finished product \nsterility testing Medtronic is retrieving any unused product manufactured from the \ndonor tissue. \n\nDonor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection", "root_cause_description": "Process change control", "action": "On 8/12/2026, recall notices were mailed or emailed to customers who were asked to do the following:\n1) Identify and quarantine any unused impacted product(s).\n2) Return affected product(s) per the return instructions in the enclosed Customer Confirmation Form. If product was purchased directly from Medtronic please contact: rs.sdmrarequest@medtronic.com,\n3) For patients already implanted with affected products, consider potential Clostridium infection if the patient presents with signs or symptoms of infection. If a patient develops an infection with clostridium at a remote site, evaluate the surgical site for potential infection.\n4) Share this Field Safety Notice with all individuals within your organization who need to be aware of this action. If any impacted products have been transferred to another organization, please ensure that a copy of this notice is provided to that organization as well.\n5) Complete and return the Customer Confirmation Form via email to neuro.quality@medtronic.com", "product_quantity": "18", "distribution_pattern": "US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.", "openfda": { "k_number": [ "K073329", "K052735", "K122513", "K091193", "K081817", "K043209", "K060794", "K053642", "K080329", "K242799", "K080399", "K113728", "K051195", "K103742", "K061668", "K050806", "K130498", "K061131", "K060180", "K060161", "K062205", "K063685", "K130703", "K063676", "K143547", "K080405", "K053098", "K061982", "K042829", "K050642", "K043048" ], "registration_number": [ "3018094310", "1043534", "3016851379", "1220477", "2011171", "3012447612", "3009672666", "3008812241", "3008650117", "2249915", "1450662", "3003828812", "2031966", "1424263", "2024024", "3010560653", "1220246", "3015724777", "3002719998", "1226544", "3005064037", "3010376334", "3005031160", "3010667733", "3012448339", "3005381997", "1032347", "3016050940", "3010331645", "3009882464", "3000215346", "1038671", "3014078231", "1030489", "1825034", "3012102437", "1000307092", "1319660", "3008522639", "3014211822", "1222747", "3003477135", "3009144915", "2090010", "2245304", "2030598", "2249062", "3012161787", "2029275", "3015231789" ], "fei_number": [ "3002980729", "3018094310", "1043534", "3016851379", "1000306431", "2011171", "1220477", "3012447612", "3009672666", "3008650117", "1450662", "3014298539", "3003828812", "3001236616", "3002719998", "2024024", "3010560653", "1220246", "3015724777", "3006813973", "1000477302", "3005064037", "3005031160", "3010667733", "3012448339", "3005381997", "1032347", "3016050940", "3010331645", "1000120776", "3009882464", "1000136478", "3000215346", "1038671", "3014078231", "3003015552", "1000518731", "1825034", "3012102437", "3003128516", "1000307092", "3008522639", "3003477135", "3009144915", "3010501626", "2245304", "3002600221", "3001503333", "3012161787", "3015231789" ], "device_name": "Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3045", "device_class": "2" } } ] }