Z-0638-2021Class II

Stimulan Kit 10cc, Model 600-010 -

Name: Z-0638-2021 Stimulan Kit 10cc, Model 600-010 -
Creator: Biocomposites, Ltd.
Published: 2020-11-12
License: https://open.fda.gov/license/

Biocomposites, Ltd. / initiated 2020-11-12 / Terminated / root cause: labeling and UDI

FDA source

Biocomposites, Ltd. began a 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 stability of the bony... on 2020-11-12. FDA classified it as Class II and gives the reason as "The product is mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0638-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-12
Posted: 2020-12-18
Terminated: 2021-04-27
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.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: The product is mislabeled.
Root cause tag: labeling and UDI
FDA 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 in commerce: 54 boxes
Distribution: Worldwide distribution - US Nationwide in the Puerto Rico and the country of Costa Rica.
Product codes and lots: Lot SK190610, Expiry June 2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0638-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0638-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18

Product code MQV

K141830Class IIStimulan Kit, Stimulan Rapid CureBiocomposites, Ltd. / cleared 2015-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)