Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CRANIOSCULPT FLOW Recalled by Skeletal Kinetics, Llc Due to Bone void filler kits may not maintain its...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Skeletal Kinetics, Llc directly.
Affected Products
CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - 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 traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Quantity: 35
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Skeletal Kinetics, Llc
Skeletal Kinetics, Llc has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report