Skeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits
Skeletal Kinetics is recalling 48 units of Craniosculpt C 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 and involves a risk of harm (incomplete bone formation, nonunion) where specific injury reports are not explicitly stated in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Skeletal Kinetics, LLC is recalling 48 units of Craniosculpt C, 3CC bone void filler kits (Product Number: C-C3CC, UDI: 813845021105). The affected lot numbers are 17110310, 1129283, and 1140612. The product is indicated to fill bony voids or gaps in the skeletal system, including extremities, spine, and pelvis, which may be surgically created or resulting from traumatic injury.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. The FDA has classified this as a Class II recall. The distribution pattern includes worldwide distribution and US nationwide distribution in the states of AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, and WI, as well as in Australia, Canada, South Africa, and Switzerland.
Use of the affected product may increase the required surgical and anesthesia time for the patient. Possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion. Healthcare providers and patients should contact Skeletal Kinetics for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - 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…
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 48
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 (3)
- Lot Numbers: 17110310
- 1129283
- 1140612.
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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