Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error
Osteomed is recalling 300 units of Osteovationex 5cc ImpactFormula bone void filler kits 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 potential failure of the product to maintain its setting characteristics due to a labeling error. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving low-risk contamination or labeling issues.
Plain-English summary
Osteomed, LLC is recalling 300 units of Osteovationex 5cc ImpactFormula bone void filler kits. The product is a medical device used to fill bone voids, which is replaced by natural bone during the healing process. The recall involves specific lots: 1128788, 1133246, 1126985, and 1135313.
The recall was initiated because the product has an incorrect shelf-life label. The source text states that the product may not maintain its setting characteristics for the duration of the labeled shelf-life. This means the product could fail to set properly if used after the expiration date indicated on the packaging.
The affected units 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 Osteomed, LLC for further instructions on how to proceed.
The recalled product
- Product
- OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Affected units
- 300
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 (3)
- LOT 1128788
- 1133246
- 1126985 and 1135313
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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