Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error
Osteomed, LLC is recalling 153 units of Osteovationex 3cc ImpactFormula bone void filler because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.
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 a moderate severity recall without reported injuries.
Plain-English summary
Osteomed, LLC is voluntarily recalling 153 units of Osteovationex 3cc ImpactFormula, a bone void filler used in medical procedures. The product is identified by Reference/UDI 390-0203/00813845020030. The recall is being conducted because the product has an incorrect shelf-life label, which means it may not maintain its required setting characteristics for the duration stated on the label.
The affected lots are 17102713, 1156491, 17051907, 1136327, and 1126984. The products were distributed worldwide, including nationwide in the United States and in Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand.
Healthcare providers and patients should check their inventory and records for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or the distributor from whom it was purchased. No specific instructions for patient management are provided in the source text, but the product should not be used if the shelf-life integrity is in question.
The recalled product
- Product
- OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Affected units
- 153
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 (4)
- LOT 17102713
- 1156491
- 17051907
- 1136327 and 1126984
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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