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Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

FDA product code MBP · Class 2 · Orthopedic

811
Registered devices
185
Adverse events
41
Recalls
31
510(k) clearances

Devices with this code

PLEXUR P® — MEDTRONIC SOFAMOR DANEK, INC.Optium® — LIFENET HEALTHArthrex® — ARTHREX, INC.Exponent — Hans Biomed Corp.Puros® — ZIMMER SPINE, INC.OsteoTorrent C — Seaspine Orthopedics CorporationReficio DBM Paste — EBI, LLCPRO-STIM — WRIGHT MEDICAL TECHNOLOGY, INC.OsteoSelect (DBM) Putty 1.0cc in a Syringe — Xtant Medical Holdings, Inc.Entice — Exactech, Inc.PLEXUR P® — MEDTRONIC SOFAMOR DANEK, INC.BellaFuse — Hans Biomed Corp.C-Blast Putty — Hans Biomed Corp.OpteCure+CCC — Exactech, Inc.PROGENIX™ PUTTY and PROGENIX™ PLUS — MEDTRONIC SOFAMOR DANEK, INC.DBM Putty 2.5cc — Xtant Medical Holdings, Inc.GRAFTON® DBM — MEDTRONIC SOFAMOR DANEK, INC.GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) — MEDTRONIC SOFAMOR DANEK, INC.PliaFX Flo — LIFENET HEALTHTrel XPress 300C — Integra Lifesciences CorporationMaxiGen — Hans Biomed Corp.DBM Putty 5cc Syringe — Xtant Medical Holdings, Inc.XEMPLIFI — GLOBUS MEDICAL, INC.Bio V BP Bioactive Glass with DBM Putty — AMEND SURGICAL, INC.

Recent recalls

DateFirmReason
2023-09-26Medtronic Sofamor Danek USA IncSpecific 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
2023-09-26Medtronic Sofamor Danek USA IncSpecific 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
2023-09-26Medtronic Sofamor Danek USA IncSpecific 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
2023-09-26Medtronic Sofamor Danek USA IncSpecific 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
2023-09-26Medtronic Sofamor Danek USA IncSpecific 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
2023-09-26Medtronic Sofamor Danek USA IncSpecific 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
2023-09-26Medtronic Sofamor Danek USA IncSpecific 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
2023-02-08Medtronic Sofamor Danek USA IncPotential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in
2023-02-08Medtronic Sofamor Danek USA IncPotential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in
2023-02-08Medtronic Sofamor Danek USA IncPotential 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.