FDA-Device2021-09-01Class II

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

BioMimetic Therapeutics, LLC
Hazard

The kit contains the wrong vial tray in the package.

Sold states
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.
Affected count
499 units
Manufactured in
389 Nichol Mill Ln # A, N/A, Franklin, TN, United States
Products
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2335-2021

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