Stimulan Kit 10cc — Class II medical device recall Z-0638-2021
Terminated recall by Biocomposites, Ltd., reported 2020-12-30, distributed nationwide. The product is mislabeled.
| Recall number | Z-0638-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocomposites, Ltd., Keele Staffordshire, N/A, United Kingdom |
| Recall initiated | 2020-11-12 |
| Classified | 2020-12-18 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2021-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR |
| Quantity | 54 boxes |
| Reason classes | labeling |
| Lot numbers | K190610 |
| Model numbers | 600-010 |
| Expiration dates | 2022-06-20 |
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.
Reason for recall
The product is mislabeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0638-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.