FDA Medical Device Recalls (openFDA)
Biocomposites, Ltd.: 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.
- Recall number
- Z-0638-2021
- Recalling firm
- Biocomposites, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2020-11-12
- Posted
- not on file
- Terminated
- 2021-04-27
- Reason
- The product is mislabeled.
- Root cause
- Labeling mix-ups
- Action
- The recalling firm contacted the 2 impacted distributors (Puerto Rico and Costa Rica) at the time of awareness of the issue. Both distributors have identified affected product, quarantined affected product and product will be returned to the recalling firm.
- Quantity
- 54 boxes
- Distribution
- Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
- Lot, serial or model codes
- Lot SK190610, Expiry June 2022
- 510(k) numbers
- ["K141830"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3002806534
- Firm city
- Keele Staffordshire
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28