BioMimetic Therapeutics, LLC recalls AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343

Recall date

July 23, 2021

Source

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

Recall number

Z-2335-2021

FDA classification

Class II

Brand / firm

BioMimetic Therapeutics, LLC

Sold / distributed

US Nationwide distribution in the states of AK, CA, CO, FL, GA, IA, ID, IL, IN, MA, MI, MN, NC, NJ, NM, NY, OH, OR, PA, TX, UT, VA, WA, and WI.

Why it was recalled

The kit contains the wrong vial tray in the package.

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

What was recalled

AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343