Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
Skeletal Kinetics is recalling 35 units of Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (incomplete bone formation, delayed union) where specific injury reports are not explicitly detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Skeletal Kinetics, LLC is recalling 35 units of Craniosculpt Flow, OUS, 5CC bone void filler kits (Product Number: C-FLOW5CC-OUS, UDI: 813845020351). The affected lots are 17100406, 1126461, 1129956, and 1141820. The product is indicated to fill bony voids or gaps in the skeletal system, including 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. This defect could increase the required surgical and anesthesia time for patients. Potential longer-term health consequences include incomplete bone formation, lack of bone formation, delayed union, or nonunion.
The affected products were distributed worldwide, including nationwide in the United States (specifically in AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, and WI) and in Australia, Canada, South Africa, and Switzerland. Healthcare providers and patients should contact Skeletal Kinetics for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- 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…
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 35
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: 17100406
- 1126461
- 1129956
- 1141820.
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.
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