Stimulan Kit 10cc recalled over labeling errors

Recall date

November 12, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Biocomposites, Ltd. recalls Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not…

Recall number

Z-0638-2021

FDA classification

Class II

Brand / firm

Biocomposites, Ltd.

Sold / distributed

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

Why it was recalled

The product is mislabeled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.