4 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - 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 EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - 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 Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020
OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - 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 MQV·April 6, 2020