Skeletal Kinetics Recalls SK Scaffold Impress 10CC Bone Void Filler Kits
Skeletal Kinetics is recalling SK Scaffold Impress 10CC 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 potential for significant health consequences (nonunion, delayed union) 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 SK Scaffold Impress 10CC bone void filler kits (Product Number: SKAF-IM10, UDI: 813845020795). The affected lots are 1134223 and 1136544. 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. The use of these products 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 products 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 should stop using the affected lots and contact Skeletal Kinetics for further instructions.
The recalled product
- Product
- SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - 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 fro
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 1
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: 1134223
- 1136544.
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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