Merz North America, Inc. recalls Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction…
- Recall date
- October 26, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0366-2016
- FDA classification
- Class II
- Brand / firm
- Merz North America, Inc.
- Sold / distributed
- 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.
Why it was recalled
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
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