Manufacturer

Skeletal Kinetics, Llc

49 recalls in our database name Skeletal Kinetics, Llc as the manufacturing or recalling firm.

What the numbers show

Total: 49
Critical: 0
Severe: 9
Most recent: 2021-01-27

Of the 49 recalls from Skeletal Kinetics, Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (18%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 49

ModerateFDA (Devices)·Z-0866-2021·2021-01-27
Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
Skeletal Kinetics is recalling 2 units of OsteoVation Inject Bone Filler Kits because of a discrepancy between the Mixing Instruction Card and the Instructions for Use.
Product
OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0867-2021·2021-01-27
Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
Skeletal Kinetics is recalling 49 units of OsteoVation bone filler kits because the mixing instructions on the card do not match the Instructions for Use.
Product
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2632-2020·2020-07-22
Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects cr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2613-2020·2020-07-22
Skeletal Kinetics Recalls Osteovation EX Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovation EX bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
Product
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, pelvis). These defects may be surgically created osseous defects or osseous defects c
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2611-2020·2020-07-22
Medtronic Bone Void Filler Recalled for Potential Failure to Set Properly
Skeletal Kinetics is recalling Medtronic Bone Void Filler kits that may not maintain setting characteristics, potentially increasing surgical time or causing bone formation issues.
Product
MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2596-2020·2020-07-22
Skeletal Kinetics Recalls Acumed Impact Bone Void Filler Kits
Skeletal Kinetics is recalling 41 units of Acumed Impact 5CC bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
Product
ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traum
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2605-2020·2020-07-22
Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
Skeletal Kinetics is recalling 125 units of Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2615-2020·2020-07-22
Skeletal Kinetics Recalls Osteovation RMX Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovation RMX bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.
Product
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 defects may be surgically created osseous defects or osseous defects created from tra
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2601-2020·2020-07-22
Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
Product
CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created f
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2631-2020·2020-07-22
Skeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits
Skeletal Kinetics is recalling SKAFFOLD RENU FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2606-2020·2020-07-22
Skeletal Kinetics Recalls Ossilix Fil Bone Void Filler Kits
Skeletal Kinetics is recalling Ossilix Fil bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.
Product
EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects cr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2630-2020·2020-07-22
Skeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits
Skeletal Kinetics is recalling SKAFFOLD RENU FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
Product
SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created fro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2620-2020·2020-07-22
Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.
Product
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). These defects may be surgically created osseous defects or osseous defects crea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2621-2020·2020-07-22
Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovationex 2cc Inject Formula bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
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). These defects may be surgically created osseous defects or osseous defects crea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2629-2020·2020-07-22
Skeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits
Skeletal Kinetics is recalling SKAFFOLD FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.
Product
SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from tra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2627-2020·2020-07-22
Skeletal Kinetics Recalls Skaflow Flow Bone Void Filler Kits
Skeletal Kinetics is recalling Skaflow Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseou
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2610-2020·2020-07-22
Medtronic Bone Void Filler Recalled for Potential Failure to Set
Skeletal Kinetics is recalling Medtronic Bone Void Filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.
Product
MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2619-2020·2020-07-22
Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.
Product
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). These defects may be surgically created osseous defects or osseous defects crea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2636-2020·2020-07-22
Skeletal Kinetics Recalls Ossilix Bone Void Filler Kits Due to Setting Defects
Skeletal Kinetics is recalling 60 units of Ossilix MP Fil bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
Product
EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects create
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2597-2020·2020-07-22
Skeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits
Skeletal Kinetics is recalling Craniosculpt C bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.
Product
CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from trau
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2600-2020·2020-07-22
Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
Skeletal Kinetics is recalling 70 units of Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created fro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2598-2020·2020-07-22
Skeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits
Skeletal Kinetics is recalling 48 units of Craniosculpt C bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from trauma
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2595-2020·2020-07-22
Skeletal Kinetics Recalls Acumed Impact Bone Void Filler Kits
Skeletal Kinetics is recalling 40 Acumed Impact bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2602-2020·2020-07-22
Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.
Product
CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects crea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2614-2020·2020-07-22
Skeletal Kinetics Recalls Osteovation Impact Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovation Impact bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing incomplete bone formation.
Product
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. extremities, spine, pelvis). These defects may be surgically created osseous de
Category
Medical Device
Distribution
Distributed nationwide