FDA-Device2016-08-31Class II
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
Merz North America, Inc.
Hazard
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Sold states
US Nationwide Distribution in the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT and WA.
Affected count
1,591 units
Manufactured in
6501 Six Forks Rd, Raleigh, NC, United States
Products
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal 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-2607-2016Don't want to check this manually?
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