Osteomed Recalls Osteovation Bone Void Filler Due to Shelf-Life Error
Osteomed is recalling 436 units of Osteovation 10cc 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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a labeling error regarding shelf-life that may affect product performance, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Osteomed, LLC is recalling 436 units of Osteovation 10cc 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 across the United States and in Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand. The specific lots involved are 1127160, 1127031, 1130303, 1138055, 1139832, and 1142076.
Healthcare providers and patients should stop using the affected lots and contact Osteomed, LLC for further instructions on how to return or dispose of the product.
The recalled product
- Product
- OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Affected units
- 436
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 1127160
- 1127031
- 1130303
- 1138055
- 1139832
- and 1142076
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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