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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-2612-2020 - OSTEOVATION EX, 3CC, IMPACT FORMULA.
Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvi...
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2
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07/15/2020
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Skeletal Kinetics, Llc
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Z-2613-2020 - 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, pelvi...
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2
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07/15/2020
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Skeletal Kinetics, Llc
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Z-2614-2020 - OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110,
UDI: 813845020092 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e....
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2
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07/15/2020
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Skeletal Kinetics, Llc
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Z-2615-2020 - OSTEOVATION RMX 10CC.
Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defec...
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2
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07/15/2020
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Skeletal Kinetics, Llc
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Z-2616-2020 - OSTEOVATION RMX 5CC.
Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defect...
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2
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07/15/2020
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Skeletal Kinetics, Llc
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Z-2617-2020 - 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)...
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2
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07/15/2020
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Skeletal Kinetics, Llc
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Z-2618-2020 - OSTEOVATION, 3CC, IMPACT FORMULA.
Product Number: 390-2103, UDI: 813845020078 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis)....
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2
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07/15/2020
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Skeletal Kinetics, Llc
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Z-2619-2020 - OSTEOVATION, 5CC, IMPACT FORMULA.
Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis)....
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2
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07/15/2020
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Skeletal Kinetics, Llc
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Z-2620-2020 - OSTEOVATION, 5CC, INJECT FORMULA.
Product Number: 390-2005, UDI: 813845020054 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis)....
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2
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07/15/2020
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Skeletal Kinetics, Llc
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Z-2621-2020 - OSTEOVATIONEX 2CC INJECT FORMULA.
Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis)....
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2
|
07/15/2020
|
Skeletal Kinetics, Llc
|