Hazard

Bone Formation Failure recalls

10 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 10
Critical: 0
Severe: 2
Most recent: 2020-07-22

Of the 10 bone formation failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (20%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all bone formation failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–10 of 10

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-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
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-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-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-2616-2020·2020-07-22
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 5CC. Product Number: 390-6001, UDI: 813845021082 - 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-2612-2020·2020-07-22
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, potentially increasing surgical time or causing bone formation issues.
Product
OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - 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
HighFDA (Devices)·Z-2593-2020·2020-07-22
Skeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits
Skeletal Kinetics is recalling Acumed Callos bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - 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 fr
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