Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovationex 5cc bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.
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 is classified as FDA Class II and involves a risk of harm (incomplete bone formation, nonunion) where specific injury reports are not explicitly detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Skeletal Kinetics, LLC is recalling Osteovationex 5cc, Inject Formula bone void filler kits. 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 involves 375 units distributed worldwide, including in the United States and countries such as Australia, Canada, South Africa, and Switzerland. Specific lot numbers affected include 17071104, 17100404, 1126669, 1128523, 1129958, 1135746, and 1142073.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. This defect could lead to increased surgical and anesthesia time for patients. Additionally, there is a risk of longer-term health consequences, including incomplete bone formation, lack of bone formation, delayed union, or nonunion.
Healthcare providers and patients who have used or possess these specific lot numbers should contact Skeletal Kinetics, LLC for further instructions on how to proceed. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - 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…
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 375
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 (7)
- Lot Numbers: 17071104
- 17100404
- 1126669
- 1128523
- 1129958
- 1135746
- 1142073.
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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