Acumed Recalls OPT Croutons Synthetic Bone Substitute Due to Sterilization Documentation Issues
Acumed LLC is recalling 83 units of OPT Croutons synthetic bone substitute because documentation for the sterilization dose was inadequate. The product was distributed in ten US states and Puerto Rico.
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, but the source text explicitly states the issue is 'inadequate documentation' and does not report any illnesses or injuries, fitting the criteria for a voluntary precautionary recall or minor labeling/documentation error.
Plain-English summary
Acumed LLC is recalling 83 units of OPT Croutons, a synthetic bone substitute made of pure beta-tricalcium phosphate, due to inadequate documentation of the sterilization dose used in production. The product, identified by part number 65-0210-S and lot 549/12.001, is designed for the repair of bony defects. The recall was initiated because the product sterilized at the site did not receive the minimum dose required per the new performance qualification.
The affected units were distributed in Florida, Indiana, Kansas, Michigan, Missouri, Nebraska, Ohio, Pennsylvania, Texas, and Puerto Rico. The source text does not specify the exact number of patients affected or report any illnesses or injuries associated with the use of this product.
Healthcare providers and patients who have used or have this product in inventory should contact Acumed LLC for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
- Manufacturer
- Acumed LLC
- Category
- Medical Device — Bone Substitute
- Affected units
- 83
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 (1)
- lot 549/12.001. Part number 65-0210-S.
Distribution
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