9 results
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36ms
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Sources: EU EUDAMED, US FDA
ALLOGRAFT
FDA Adverse Event
ALLOSOURCE, INC.·Product code LMO·December 29, 1999
ALLOFUSE CORTICAL CERVICAL SPACERS
FDA Adverse Event
Malfunction
·ALLOSOURCE INC·Product code MQV·February 20, 2019
ALLOFUSE CORTICAL CERVICAL SPACERS 4521 SERIES
FDA Adverse Event
Injury
·ALLOSOURCE, INC.·Product code MQV·March 19, 2019
DYNABLAST PUTTY 5CC
FDA Adverse Event
Injury
·KEYSTONE DENTAL·Product code NUN·October 28, 2011
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.
FDA Recall
Terminated
·AlloSource, Inc.·Product code MQV·March 25, 2014
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.
FDA Enforcement
Class II
·Terminated·AlloSource, Inc.·May 14, 2014
XEMPLIFI DBM PUTTY
FDA Adverse Event
Injury
·ALLOSOURCE·Product code MBP·January 2, 2018
XEMPLIFI DBM PUTTY
FDA Adverse Event
Injury
·ALLOSOURCE·Product code MBP·January 2, 2018
XEMPLIFI DBM PLUS
FDA Adverse Event
Injury
·ALLOSOURCE·Product code MBP·January 2, 2018