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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classifies this as a Class II recall, and the source text describes potential significant health consequences including incomplete bone formation, delayed union, or nonunion, which aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.
Plain-English summary
Skeletal Kinetics, LLC is recalling 125 units of Craniosculpt Flow 5cc bone void filler kits (Product Number: C-FLOW5CC, UDI: 813845020337). The affected lot numbers are 1129763, 1137730, 1141819, and 1144572. The product is indicated to fill bony voids or gaps of the skeletal system, including those in the extremities, spine, and pelvis.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. The agency classifies this as a Class II recall. The distribution pattern includes worldwide distribution, specifically US nationwide distribution in states such as AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, and WI, as well as in Australia, Canada, South Africa, and Switzerland.
Use of the affected product may increase the required surgical and anesthesia time for the patient. Possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion. Healthcare providers and patients should contact Skeletal Kinetics, LLC for further instructions regarding the recall.
The recalled product
- 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
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: 1129763
- 1137730
- 1141819
- 1144572.
Distribution
Part of a larger recall action
This product is one of 45 recalled by Skeletal Kinetics, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 45 products in this recall →Related recalls
Same manufacturer · Skeletal Kinetics, Llc
See all →- ModerateSkeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
FDA (Devices) · 2021-01-27
- ModerateSkeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
FDA (Devices) · 2021-01-27
- HighSkeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits
FDA (Devices) · 2020-07-22
Same hazard · incomplete bone formation
See all →- SevereSkeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Ossilix Fil Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- SevereSkeletal Kinetics Recalls Osteovation EX Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits
FDA (Devices) · 2020-07-22