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.
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, 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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