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, potentially increasing surgical time or causing bone formation issues.
What this means for you
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 without reported injury.
Plain-English summary
Skeletal Kinetics, LLC is recalling 35 units of Craniosculpt Flow, Can, 5CC (Product Number: C-FLOW5CC-CAN, UDI: 813845020344). The affected lots are 17100405 and 1129762. The product is a bone void filler indicated to fill bony voids or gaps of the skeletal system, such as those in the extremities, spine, or pelvis.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. If used, this defect may increase the required surgical and anesthesia time for the patient. Possible longer-term health consequences include incomplete bone formation, lack of bone formation, delayed union, or nonunion.
The product was 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 stop using the affected product and contact Skeletal Kinetics for further instructions.
The recalled product
- Product
- CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - 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
- 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 (2)
- Lot Number: 17100405
- 1129762.
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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