Medtronic Sofamor Danek USA Inc Recalls
2 recalls on record in the United States
Medtronic Sofamor Danek USA Inc recalls Grafton" DBM and Grafton Plus" DBM contain demineralized hum
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.
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Medtronic Sofamor Danek USA Inc recalls Grafton" DBM and Grafton Plus" DBM contain demineralized hum
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
View recall details →