Home › Device types › MBP
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
FDA product code MBP · Class 2 · Orthopedic
815
Registered devices
186
Adverse events
43
Recalls
31
510(k) clearances
Devices with this code
PLEXUR P® — MEDTRONIC SOFAMOR DANEK, INC.OsteoSurge 300 Putty — ISOTIS ORTHOBIOLOGICS, INC.OSTEOSET — WRIGHT MEDICAL TECHNOLOGY, INC.PliaFX Flo — LIFENET HEALTHBackpack AF — Ventris MedicalOsteoSparx C Putty — ISOTIS ORTHOBIOLOGICS, INC.BEAST PLUS — Xtant Medical Holdings, Inc.DBM Putty 1.0cc — Xtant Medical Holdings, Inc.N/A — BIOMET MICROFIXATION, INCEquivaBone ® — Etex CorporationArthrex® — ARTHREX, INC.BIO DBM — Stryker CorporationOsteoSelect PLUS DBM Putty 10.0cc — Xtant Medical Holdings, Inc.Trel-XC Putty — Integra Lifesciences CorporationOsteoSelect PLUS DBM Putty 2.5cc — Xtant Medical Holdings, Inc.NA — Stryker CorporationBellaFuse — Hans Biomed Corp.DBM Putty 2.5cc Syringe — Xtant Medical Holdings, Inc.GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) — MEDTRONIC SOFAMOR DANEK, INC.Propel — Nuvasive, Inc.Hero DBM Putty, 1.0cc — Xtant Medical Holdings, Inc.BIO DBM — Stryker CorporationAlphaGRAFT — ALPHATEC SPINE, INC.TruForm+ — Hans Biomed Corp.
Recent 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 |
| 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 |
| 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 acc |
| 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 acc |
| 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 acc |
| 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 acc |
| 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 acc |
| 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 acc |
| 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 acc |
| 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 |
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