Skeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits
Skeletal Kinetics is recalling SKAFFOLD RENU 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 agency classification is FDA Class II, and the source text explicitly lists potential significant injury reports such as incomplete bone formation, lack of bone formation, delayed union, or nonunion, which aligns with the 'Severe' criteria for significant injury reports.
Plain-English summary
Skeletal Kinetics, LLC is recalling 86 units of SKAFFOLD RENU FLOW, 5CC bone void filler kits (Product Number: SKMA-FL05, UDI: 813845020849). The recall covers Lot Numbers 16051601 and 17120620. The product is indicated to fill bony voids or gaps in the skeletal system, including extremities, spine, and 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 affected products were distributed worldwide, including nationwide distribution in the United States 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 RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - 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
- 86
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 Number: 16051601
- 17120620.
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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