FDA recall Z-2335-2021

Product

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

Reason for recall

The kit contains the wrong vial tray in the package.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2021-07-23

Report date

2021-09-01

Termination date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin, TN, United States

Primary source

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