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.
Reported: August 31, 2016 Initiated: May 20, 2016 #Z-2607-2016
Product Description
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.
Reason for Recall
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Details
- Recalling Firm
- Merz North America, Inc.
- Units Affected
- 1,591 units
- Distribution
- 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.
- Location
- Raleigh, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merz North America, Inc.. Units affected: 1,591 units.
Why was this product recalled? ▼
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2607-2016.
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