3 results
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26ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Recall
Terminated
·Osteomed, LLC·Product code MQV·April 2, 2020
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Recall
Terminated
·Skeletal Kinetics, Llc·Product code GXP·June 6, 2019
OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Recall
Terminated
·Skeletal Kinetics, Llc·Product code GXP·April 6, 2020