Osteomed Recalls Osteovation RMX Injectable Due to Shelf-Life Labeling Error
Osteomed, LLC is recalling 651 units of Osteovation RMX 10 CC Injectable bone void filler kits 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 corresponds to a moderate severity where the product may cause temporary or medically reversible health problems. The specific hazard is a labeling error regarding shelf-life, which is a lower-risk defect compared to active contamination or structural failure.
Plain-English summary
Osteomed, LLC is recalling 651 units of Osteovation RMX 10 CC Injectable, 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 Reference/UDI 390-6002/ /00813845021099. The recall includes specific lot numbers: 1127902, 1129603, 1132560, 1134444, 1137073, 1141342, and 1142084. The product was distributed worldwide, including nationwide in the United States and in Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand.
The FDA has classified this as a Class II recall. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Hazard
- Affected units
- 651
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 1127902
- 1129603
- 1132560
- 1134444
- 1137073
- 1141342 and 1142084
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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