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Skeletal Kinetics Recalls
49 recalls on record · August 5, 2015 to January 27, 2021 · Medical Devices
Recalls by year
15
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - Product Usage: Callos is indicated to
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fi
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fi
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to f
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill b
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bon
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony void
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony void
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to fill bony voids or gaps of th
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bon
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bo
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bo
Hazard: Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
May 27, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bon
Hazard: Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.
August 5, 2015Medical DevicesFDA
Skeletal Kinetics, Llc recalls InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized u
Hazard: Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.