# FDA recall Z-0638-2021

> **Biocomposites, Ltd.** · Class II · device recall initiated 2020-11-12.

## 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.

## Distribution

Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.

## Key facts

- **Recall number:** Z-0638-2021
- **Recalling firm:** Biocomposites, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-12
- **Report date:** 2020-12-30
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Keele Staffordshire, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0638-2021

## Citation

> AI Analytics. FDA recall Z-0638-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0638-2021. Source: US FDA. Licensed CC0.

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