Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error
Osteomed, LLC is recalling 647 units of Osteovationex 5cc Inject Formula 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 moderate severity without reported injuries.
Plain-English summary
Osteomed, LLC is recalling 647 units of Osteovationex 5cc Inject Formula, a bone void filler used in medical procedures. The recall is due to an incorrect shelf-life label, which means the product may not maintain its required setting characteristics for the duration stated on the packaging.
The affected product is distributed worldwide, including nationwide in the United States and in several international countries such as Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand. The specific lot numbers involved are 1128523, 1129958, 1135746, 1142073, 17071104, 17100404, and 1126669.
Healthcare providers and patients should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Affected units
- 647
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 1128523
- 1129958
- 1135746
- 1142073
- 17071104
- 17100404 and 1126669
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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