{"recall":{"id":"fda-device-99701","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medtronic Sofamor Danek USA Inc recalls 2 products","firm":"Medtronic Sofamor Danek USA Inc","date":"2026-08-12","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch\" and Orthoblend are produced from a fiber form of DBM Crunch\" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are malleable and can be molded or cut into various sizes and shapes according to the intended implant site.","code":"UDI-DI: 00643169123021. Serial Numbers: A62881-034 through A62881-051, specifically: A62881-034, A62881-035, A62881-036, A62881-037, A62881-038, A62881-039, A62881-040, A62881-041, A62881-042, A62881-043, A62881-044, A62881-045, A62881-046, A62881-047, A62881-048, A62881-049, A62881-050, A62881-051","quantity":"18","number":"Z-0137-2027","classification":"Class II"},{"name":"Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch\" and Orthoblend are produced from a fiber form of DBM Crunch\" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are malleable and can be molded or cut into various sizes and shapes according to the intended implant site.","code":"UDI-DI: 00643169122932. Serial Numbers: A62881-014 through A62881-033, specifically: A62881-014, A62881-015, A62881-016, A62881-017, A62881-018, A62881-019, A62881-020, A62881-021, A62881-022, A62881-023, A62881-024, A62881-025, A62881-026, A62881-027, A62881-028, A62881-029, A62881-030, A62881-031, A62881-032, A62881-033","quantity":"20","number":"Z-0138-2027","classification":"Class II"}],"reason":"Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.","nationwide":true,"states":[],"units":"18; 20","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99701","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"04de96176c7bddd8","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99701","record":[{"status":"Ongoing","city":"Memphis","state":"TN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99701","recalling_firm":"Medtronic Sofamor Danek USA Inc","address_1":"1800 Pyramid Pl","address_2":"","postal_code":"38132-1703","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.","recall_number":"Z-0137-2027","product_description":"Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue  combined with an inert additive to yield a demineralized bone matrix (DBM)  allograft product having a particular physical form and/or handling property.  Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form  of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch\" and Orthoblend are  produced from a fiber form of DBM Crunch\" also contains demineralized bone  chips/cubes, while Grafton DBM Orthoblend contains non-demineralized  cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are  malleable and can be molded or cut into various sizes and shapes according to the  intended implant site.","product_quantity":"18","reason_for_recall":"Medtronic identified through donor record review that the donor for Medtronic  batch A62881 did not meet all Medtronic donor eligibility requirements related to  the presence of microbial organisms.  While the batch passed finished product  sterility testing Medtronic is retrieving any unused product manufactured from the  donor tissue.    Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection","recall_initiation_date":"20260812","center_classification_date":"20261009","report_date":"20261021","code_info":"UDI-DI: 00643169123021. Serial Numbers: A62881-034 through A62881-051, specifically:  A62881-034, A62881-035, A62881-036, A62881-037, A62881-038, A62881-039, A62881-040, A62881-041, A62881-042, A62881-043, A62881-044, A62881-045, A62881-046, A62881-047, A62881-048, A62881-049, A62881-050, A62881-051","more_code_info":""},{"status":"Ongoing","city":"Memphis","state":"TN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99701","recalling_firm":"Medtronic Sofamor Danek USA Inc","address_1":"1800 Pyramid Pl","address_2":"","postal_code":"38132-1703","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.","recall_number":"Z-0138-2027","product_description":"Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch\" and Orthoblend are produced from a fiber form of DBM Crunch\" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are malleable and can be molded or cut into various sizes and shapes according to the intended implant site.","product_quantity":"20","reason_for_recall":"Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue.  Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.","recall_initiation_date":"20260812","center_classification_date":"20261009","report_date":"20261021","code_info":"UDI-DI: 00643169122932. Serial Numbers: A62881-014 through A62881-033, specifically: A62881-014, A62881-015, A62881-016, A62881-017, A62881-018, A62881-019, A62881-020, A62881-021, A62881-022, A62881-023, A62881-024, A62881-025, A62881-026, A62881-027, A62881-028, A62881-029, A62881-030, A62881-031, A62881-032, A62881-033","more_code_info":""}]}}