Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error
Osteomed, LLC is recalling Osteovationex 3cc Inject Formula bone void fillers because the product may not maintain its setting characteristics for the labeled shelf-life duration.
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, and the hazard involves a labeling error regarding shelf-life that may affect product performance, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Osteomed, LLC is recalling 270 units of Osteovationex 3cc Inject Formula, a bone void filler that is replaced by bone during the healing process. The recall is due to an incorrect shelf-life label; the product may not maintain its setting characteristics for the duration stated on the label.
The affected product is identified by Reference/UDI 390-0003/00813845020016 and includes lots 17100402, 1127942, 1130302, 1135740, 1142070, and 1142943. The product was distributed worldwide, including nationwide in the United States and in Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand.
Healthcare providers and patients should stop using the affected product and contact Osteomed, LLC for further instructions.
The recalled product
- Product
- OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Affected units
- 270
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 (6)
- LOT 17100402
- 1127942
- 1130302
- 1135740
- 1142070
- 1142943
Distribution
Part of a larger recall action
This product is one of 12 recalled by Osteomed, 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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