Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits
Skeletal Kinetics is recalling Craniosculpt bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
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 defect that could lead to significant health consequences such as nonunion or delayed union, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Skeletal Kinetics, LLC is recalling 32 units of Craniosculpt, CMF Impact, 5CC bone void filler kits (Product Number: C-CMF5CC, UDI: 813845020948, Lot Number: 17040541). The product is indicated to fill bony voids or gaps in the skeletal system, such as those in the extremities, spine, or pelvis, and is designed to resorb and be replaced by bone during the healing process.
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 affected products were distributed worldwide, including nationwide distribution in the United States (AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, WI) and in Australia, Canada, South Africa, and Switzerland. Healthcare providers and patients should contact Skeletal Kinetics for further instructions on how to proceed with the recall.
The recalled product
- Product
- CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - 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
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 32
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: 17040541.
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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