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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when significant injury or health consequences like nonunion are described.
Plain-English summary
Skeletal Kinetics, LLC is recalling 260 units of Craniosculpt Flow, 10CC bone void filler kits. The product is indicated to fill bony voids or gaps of the skeletal system, including those in the extremities, spine, and pelvis. The recall covers specific lot numbers: 17040528, 17100408, 1126463, 1127977, 1129766, 1137084, 1139620, and 1141816.
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, US nationwide distribution in specific states (AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, WI), and international distribution to 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, LLC for further instructions on how to handle the recalled product.
The recalled product
- Product
- CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - 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
- 260
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: 17040528
- 17100408
- 1126463
- 1127977
- 1129766
- 1137084
- 1139620
- 1141816.
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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