Hazard

Incomplete Bone Formation recalls

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

What the numbers show

Total: 11
Critical: 0
Severe: 4
Most recent: 2020-07-22

Of the 11 incomplete bone formation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (36%) 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 incomplete bone formation 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.

1–11 of 11

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…
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-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…
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2624-2020·2020-07-22
Skeletal Kinetics Recalls SK Scaffold Impress 10CC Bone Void Filler Kits
Skeletal Kinetics is recalling SK Scaffold Impress 10CC bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
Product
SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - 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-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…
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2608-2020·2020-07-22
Skeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits
Skeletal Kinetics is recalling 20 units of Ossilix Form bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - 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…
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2628-2020·2020-07-22
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 incomplete bone formation.
Product
SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - 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-2389-2020·2020-06-24
Medtronic Bone Void Filler Kit Recalled for Setting Defects
Medtronic is recalling 41 units of Bone Void Filler Kits because the product may not set properly, potentially increasing surgical time and causing incomplete bone formation.
Product
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Category
Medical Device
Distribution
Distributed nationwide