Skeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits
Skeletal Kinetics is recalling SKAFFOLD FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing incomplete bone formation.
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 is classified as FDA Class II. The hazard involves a risk of harm (incomplete bone formation, delayed union) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Skeletal Kinetics, LLC is recalling 41 units of SKAFFOLD FLOW (MX) 5CC bone void filler kits (Product Number: SKMX-FL05, UDI: 813845020894). The affected lots are 1136227 and 1137065. 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 was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. If the product fails to set properly, it may increase the required surgical and anesthesia time for the patient. Potential longer-term health consequences include incomplete bone formation, lack of bone formation, delayed union, or nonunion.
The affected units were distributed worldwide, including nationwide in the United States (specifically in AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, and WI) and in Australia, Canada, South Africa, and Switzerland. Healthcare providers and patients should stop using the affected lots and contact Skeletal Kinetics for further instructions.
The recalled product
- Product
- SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - 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
- 41
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 (2)
- Lot Numbers: 1136227
- 1137065.
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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