FDA Device recall Z-0638-2021
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 st…
- FDA Device
- Class II
- terminated
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of 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 st… by Biocomposites, citing the product is mislabeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0638-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-12 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biocomposites |
| Distribution | US |
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
The product is mislabeled.
Identifiers
| code_info | Lot SK190610, Expiry June 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0638-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.