Class 2 Device Recall Grafton" Orthoblend (Product T44150) and Grafton" Paste (Product T45005)

• Date Initiated by Firm: August 12, 2026
• Date Posted: October 09, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0137-2027
• Recall Event ID: 99701
• 510(K)Number: K042707 K043048
• Product Classification: Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
• Product: 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 Information: 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
• FEI Number: 1000477302
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Pl; Memphis TN 38132-1703
• For Additional Information Contact: Christine Stewart; 269-377-2557
• Manufacturer 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
• FDA Determined Cause: Process change control
• Action: On 8/12/2026, recall notices were mailed or emailed to customers who were asked to do the following: 1) Identify and quarantine any unused impacted product(s). 2) 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, 3) 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. 4) 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. 5) Complete and return the Customer Confirmation Form via email to neuro.quality@medtronic.com
• Quantity in Commerce: 18
• Distribution: US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MBP