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Every Skeletal Kinetics, Llc Recall

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35 recalls
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids...
Surgical Devices·88 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or g...
Surgical Devices·60 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids ...
Surgical Devices·31 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or...
Surgical Devices·35 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: Callos is indicated to fill bony voids o...
Surgical Devices·375 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or...
Surgical Devices·1,393 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the...
Surgical Devices·379 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or...
Surgical Devices·12 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or ga...
Surgical Devices·1,053 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids ...
Surgical Devices·121 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps o...
Surgical Devices·442 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·217 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gap...
Surgical Devices·27 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the...
Surgical Devices·54 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·51 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps o...
Surgical Devices·70 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of ...
Surgical Devices·41 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids ...
Surgical Devices·10 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - Product Usage: Callos is in...
Surgical Devices·661 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the ...
Surgical Devices·111 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps ...
Surgical Devices·379 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps ...
Surgical Devices·184 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·4 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill...
Surgical Devices·29 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids o...
Surgical Devices·116 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony voids or gaps of the ...
Surgical Devices·263 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or...
Surgical Devices·35 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the sk...
Surgical Devices·48 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the ...
Surgical Devices·307 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·35 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or ga...
Surgical Devices·491 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or ga...
Surgical Devices·32 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of ...
Surgical Devices·125 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler ind...
Surgical Devices·125 affected·Apr 3, 2020
High RiskFDA
Skeletal Kinetics, Llc
OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides ...
Medical Devices·2 affected·Jun 6, 2019