Skeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits
Skeletal Kinetics is recalling Craniosculpt C 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 involves a medical device with a risk of harm (incomplete bone formation, increased surgical time) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Skeletal Kinetics, LLC is recalling 307 units of Craniosculpt C, 10CC bone void filler kits. The product is indicated to fill bony voids or gaps in the skeletal system, such as those in the extremities, spine, or pelvis. The recall covers specific lot numbers: 17110307, 1126715, 1129289, 1137080, 1139373, 1139829, 1141989, and 1143094.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. If the product does not set properly, its use may increase the required surgical and anesthesia time for the patient. Additionally, longer-term health consequences could include incomplete bone formation, lack of bone formation, delayed union, or nonunion.
The affected products were distributed worldwide, including nationwide in the United States and in Australia, Canada, South Africa, and Switzerland. Healthcare providers and patients who have used these specific lots should contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - 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 trau
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 307
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 (8)
- Lot Numbers: 17110307
- 1126715
- 1129289
- 1137080
- 1139373
- 1139829
- 1141989
- 1143094.
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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