Osteomed Recalls Osteovation RMX Injectable Bone Void Filler Kits
Osteomed is recalling 278 units of Osteovation RMX Injectable Bone Void Filler kits due to incorrect shelf-life labeling that may affect product 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, and the source text explicitly states no illnesses or injuries have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
Osteomed, LLC is recalling 278 units of Osteovation RMX Injectable Bone Void Filler kits. The recall is due to incorrect shelf-life labeling, which means the product may not maintain its setting characteristics for the duration stated on the label.
The affected product is a bone void filler that is replaced by bone during the healing process. The recall includes specific lot numbers: 1125793, 1129602, 1132492, 1132347, 1134448, 1137064, and 1142080. The product was distributed worldwide, including in the United States and in Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand.
Healthcare providers and patients who have used or possess these specific lots of the product should contact Osteomed, LLC for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Affected units
- 278
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 1125793
- 1129602
- 1132492
- 1132347
- 1134448
- 1137064 and 1142080
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.
See all 12 products in this recall →Related recalls
Same manufacturer · Osteomed, LLC
See all →- HighOsteomed AutoDrive Screws Recalled for Undersized Screw Head
FDA (Devices) · 2023-07-19
- HighOrthopedic Screw Recall Due to Undersized Head in Surgical Device
FDA (Devices) · 2023-07-19
- SevereOsteoMed Surgical Consoles Recalled for Electrical Safety Violations
FDA (Devices) · 2021-12-15
- ModerateOsteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error
FDA (Devices) · 2020-06-10
- ModerateOsteomed Recalls Osteovation RMX Injectable Due to Shelf-Life Labeling Error
FDA (Devices) · 2020-06-10
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02