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INFUSE® Bone Graft

MEDTRONIC SOFAMOR DANEK, INC. · Model 7510200 · UDI-DI 00681490843782

NEKNPZ Prescription
0
510(k) clearances
13,040
Adverse events (45 deaths)
8
Recalls
5
Facilities

Description

BONE GRAFT KIT 7510200 INFUSE SMALL

Recalls

DateFirmReason
2018-09-27Medtronic Sofamor Danek USA IncThe Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
2013-05-28Medtronic Sofamor Danek USA IncKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
2013-05-28Medtronic Sofamor Danek USA IncKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
2013-05-28Medtronic Sofamor Danek USA IncKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
2013-05-28Medtronic Sofamor Danek USA IncKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
2013-05-28Medtronic Sofamor Danek USA IncKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
2013-05-28Medtronic Sofamor Danek USA IncKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
2013-05-28Medtronic Sofamor Danek USA IncKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

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Data 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.