The Recall Desk
ModerateFDA (Devices)·Z-0638-2021·Announced 2020-12-30

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.

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, 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.
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

Distributed nationwide across the United States.

The notice also names 1 state specifically: