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GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
MEDTRONIC SOFAMOR DANEK, INC. · Model P42275 · UDI-DI 00613994985811
1
510(k) clearances
185
Adverse events (1 deaths)
43
Recalls
48
Facilities
Description
DBM P42275 8MMX1CMX10CM 2 EACH GRAFTON M
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-12 | Medtronic Sofamor Danek USA Inc | 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 mi |
| 2026-08-12 | Medtronic Sofamor Danek USA Inc | 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 micr |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-09-26 | Medtronic Sofamor Danek USA Inc | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requiremen |
| 2023-02-08 | Medtronic Sofamor Danek USA Inc | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.