Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
Skeletal Kinetics is recalling 49 units of OsteoVation bone filler kits because the mixing instructions on the card do not match the Instructions for Use.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that no customer complaints or reports of injury have been received, and the hazard is a labeling discrepancy rather than a physical defect or contamination.
Plain-English summary
Skeletal Kinetics, LLC is recalling 49 units of OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303). The recall was initiated after a discrepancy was identified between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10cc bone void filler kits.
The affected products were distributed nationwide in the United States, including in Texas, New York, Florida, and Arizona. The product is a bone void filler intended to be replaced by bone during the healing process.
No customer complaints or reports of injury have been received. The FDA has classified this as a Class II recall.
The recalled product
- Product
- OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Skeletal Kinetics, Llc
- Hazard
- Affected units
- 49
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 (5)
- OsteoVation
- Inject
- 10cc (part number 390-2010
- manufacturing lot 1130303
- label no 12464). UDI (2): (01) 0 0813845 02006 1 (17) 210501 (10) 1130303
Distribution
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
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