FDAFDA · Food and drugs·Recall number Z-2607-2016
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.
Published August 31, 2016 · Recall initiated: May 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merz North America, Inc.
- Distributor
- 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.
- Lot
- Model number: 8063M0K1, Lot #100088744.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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