Class II — Biocomposites, Ltd.
| Recalling firm | Biocomposites GmbH (former ARTOSS GmbH) |
|---|---|
| Registered facility | Biocomposites GmbH (former ARTOSS GmbH) (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The product is mislabeled. |
| 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. |
| Quantity | 54 boxes |
| Distribution | Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica. |
| Initiated | 2020-11-12 |
| Classified | 2020-12-18 |
| Terminated | 2021-04-27 |
| Recall number | Z-0638-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biocomposites, Ltd. (Z-0638-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86755/
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