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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.
January 27, 2021Medical DevicesFDA
Skeletal Kinetics, Llc recalls OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The produc
Hazard: A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
January 27, 2021Medical DevicesFDA
Skeletal Kinetics, Llc recalls OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The
Hazard: A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
July 22, 2020Medical DevicesFDA
Skeletal Kinetics, Llc recalls EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fil
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, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - 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, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill
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, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill
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, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - 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 SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - 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 SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - 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 SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voi
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 SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - 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 SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is
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 SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - 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 SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - 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 SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - 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 OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - 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 OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - 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 OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - 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 OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 813845020054 - 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 OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - 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 OSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 813845020078 - 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 OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - 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 OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - 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 OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voi
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 OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - Product Us
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 OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated t
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 OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated t
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 MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill
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 MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill
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 FORM (MX), 5CC. Product Number: 660-01-05, UDI: 813845021020 - 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.