FDA-Device2015-12-09Class II
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
Merz North America, Inc.
Hazard
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Sold states
Nationwide Distribution including the states of AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI.
Affected count
1,616 units
Manufactured in
6501 Six Forks Rd, Raleigh, NC, United States
Products
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0366-2016Don't want to check this manually?
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