Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits
Skeletal Kinetics is recalling 27 units of Craniosculpt 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 involves a medical device with potential for significant health consequences (nonunion, lack of bone formation) but no reported 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 27 units of Craniosculpt, CMF Impact, 3CC bone void filler kits (Product Number: C-CMF3CC, Lot Number: 17040538). The recall is due to a defect where the kits may not maintain their setting characteristics for the labeled shelf-life duration.
The affected product is indicated to fill bony voids or gaps of the skeletal system, including extremities, spine, and pelvis. The kits were distributed worldwide, including nationwide in the United States and 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 include incomplete bone formation, lack of bone formation, delayed union, or nonunion.
The recalled product
- Product
- CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - 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
- 27
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: 17040538.
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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