Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
Skeletal Kinetics is recalling 2 units of OsteoVation Inject Bone Filler Kits because of a discrepancy between the Mixing Instruction Card and 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 Moderate because it involves a labeling discrepancy (minor labeling error) and the source explicitly states that no customer complaints or reports of injury have been received.
Plain-English summary
Skeletal Kinetics, LLC is recalling 2 units of OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957). The product is a bone void filler that is replaced by bone during the healing process.
The recall was initiated because a discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10cc bone void filler kits. The source text states that no customer complaints or reports of injury have been received.
The affected units were distributed nationwide in the United States, including in the states of Texas, New York, Florida, and Arizona. Healthcare providers and patients should stop using the affected product and contact Skeletal Kinetics for further instructions.
The recalled product
- Product
- OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - 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
- 2
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
- 5cc (part number 390-2005
- manufacturing lot number 1129957
- label no. 12464) . UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957
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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