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Merz North America, Inc. recalls Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE i
Recalled August 31, 2016 · FDA recall Z-2607-2016 · Merz North America
Hazard
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. · FDA Class II
Units
1,591 units
Sold at
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.
Description
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Product
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.
Manufacturer(s)
Merz North America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →