Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error
Osteomed, LLC is recalling 70 units of Osteovationex 2cc Inject Formula because the product may not maintain its setting characteristics for the labeled shelf-life duration.
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, and the hazard involves a product performance issue (setting characteristics) rather than a direct acute health threat like infection or injury, fitting the criteria for moderate severity.
Plain-English summary
Osteomed, LLC is recalling 70 units of Osteovationex 2cc Inject Formula, a bone void filler used in medical procedures. The recall was initiated because the product has an incorrect shelf-life label; specifically, the product may not maintain its setting characteristics for the duration stated on the label.
The affected lots are 1135741, 1130301, and 1127941. The product was distributed worldwide, including nationwide in the United States and in Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand.
Healthcare providers and patients should stop using the affected product and contact Osteomed, LLC for further instructions or a replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Hazard
- Affected units
- 70
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 1135741
- 1130301
- 1127941
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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