Home / Recalls / Medical Devices
Merz North America, Inc. recalls Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction
Recalled December 9, 2015 · FDA recall Z-0366-2016 · Merz North America
Hazard
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. · FDA Class II
Units
1,616 units
Sold at
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.
Description
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Product
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal 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 →