Osteomed Recalls Osteovation 5cc Impactformula Bone Void Filler Kits
Osteomed is recalling Osteovation 5cc Impactformula bone void filler kits 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding shelf-life that affects product performance, without reported injuries or deaths.
Plain-English summary
Osteomed, LLC is recalling Osteovation 5cc Impactformula bone void filler kits. The product is a bone void filler that is replaced by bone during the healing process. The recall involves 1,724 units distributed worldwide, including across the United States and in Australia, Italy, Korea, Malaysia, Peru, Singapore, and Thailand.
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 labeled shelf-life. This could affect the performance of the device during the healing process.
The affected lots are 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043, and 1142210. Healthcare providers and patients should check their inventory or medical records for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Manufacturer
- Osteomed, LLC
- Hazard
- Affected units
- 1,724
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 (9)
- LOT 17060509
- 17102710
- 17040533
- 17051911
- 1126986
- 1128789
- 1134232
- 1136330
- 1144043 and 1142210
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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