Biocomposites Recalls Stimulan Kit 10cc Due to Mislabeled Product
Biocomposites, Ltd. is recalling 54 boxes of Stimulan Kit 10cc, Model 600-010, because the product is mislabeled. The recall affects units distributed in the US, Puerto Rico, and Costa Rica.
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 only cites mislabeling as the reason without reporting specific injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Biocomposites, Ltd. is recalling 54 boxes of Stimulan Kit 10cc, Model 600-010. The product is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. The recall is being conducted because the product is mislabeled.
The affected units are identified by Lot SK190610 with an expiry date of June 2022. Distribution was worldwide, specifically including the United States, Puerto Rico, and Costa Rica.
Consumers and healthcare providers should stop using the affected product and contact Biocomposites, Ltd. for further instructions or a refund.
The recalled product
- Product
- Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.
- Manufacturer
- Biocomposites, Ltd.
- Hazard
- Affected units
- 54
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 (2)
- Lot SK190610
- Expiry June 2022
Distribution
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