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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K162864
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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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CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicat... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicat... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callo... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos i... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos ... 2 07/15/2020 Skeletal Kinetics, Llc
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a c... 2 05/20/2020 Skeletal Kinetics, Llc
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