Osteomed Recalls Osteovation 3CC ImpactFormula Bone Void Filler Kits
Osteomed is recalling 409 units of Osteovation 3CC ImpactFormula bone void filler kits due to incorrect shelf-life labeling that may affect product 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding shelf-life that affects product performance, without reported injuries or illnesses.
Plain-English summary
Osteomed, LLC is recalling 409 units of Osteovation 3CC ImpactFormula bone void filler kits. The product is a medical device used to provide a bone void filler that is replaced by bone during the healing process. The recall involves specific lot numbers: 17051908, 17060107, 1132179, 1133245, 1135308, and 1142208.
The recall was initiated because the kits have an incorrect shelf-life label. The product may not maintain its setting characteristics for the duration stated on the labeled shelf-life. This issue could impact the performance of the device during use.
The affected products were distributed worldwide, including nationwide in the United States and in Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand. Healthcare providers and patients who have used or have these specific lots of the product should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Affected units
- 409
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)
- LOT 17051908
- 17060107
- 1132179
- 1133245
- 1135308 and 1142208
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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