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.
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 classification is FDA Class II, and the source text describes potential significant injury reports including incomplete bone formation, lack of bone formation, delayed union, or nonunion, which aligns with the 'Severe' criteria for Class II recalls with significant injury reports.
Plain-English summary
Skeletal Kinetics, LLC is recalling Craniosculpt Flow bone void filler kits, specifically the 10cc can product (Product Number: C-FLOW10CC-CAN, UDI: 813845020375). The recall involves Lot Number 17100409. The product is indicated to fill bony voids or gaps of the skeletal system, including those in the extremities, spine, and pelvis.
The recall is being issued because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. If the product fails to set properly, use 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 affected products were distributed worldwide, including nationwide distribution in the United States and in Australia, Canada, South Africa, and Switzerland. Healthcare providers and patients who have used or possess this specific lot of Craniosculpt Flow should contact Skeletal Kinetics, LLC for further instructions on how to proceed.
The recalled product
- 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 cr
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 10
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 (1)
- Lot Number: 17100409.
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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