Osteomed Recalls Osteovation Bone Void Filler Due to Shelf-Life Error
Osteomed, LLC is recalling 417 units of Osteovation 5cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.
What this means for you
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, but the source text describes a labeling error regarding shelf-life without reporting any specific injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Osteomed, LLC is recalling 417 units of Osteovation 5cc Inject Formula, a bone void filler used in medical procedures. The recall was initiated because the product has an incorrect shelf-life label. The source text indicates that the product may not maintain its setting characteristics for the duration stated on the label.
The affected product is identified by the UDI 390-2005/00813845020054. The specific lot numbers involved in this recall are 17040525, 1127972, 17071105, 1129957, and 1135744. The product was distributed worldwide, including nationwide in the United States and in several international countries such as Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand.
This recall is classified as Class II by the FDA. 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 disposed of according to local regulations, as the setting properties may not be reliable beyond the intended shelf-life.
The recalled product
- Product
- OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Affected units
- 417
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 17040525
- 1127972
- 17071105
- 1129957
- and 1135744.
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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