Device 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.
Z-2607-2016
Product summary
- Event
- Event 74252
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,591 units
- Official record key
device-enforcement:Z-2607-2016
Official wording
Reason: Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Code information: Model number: 8063M0K1, Lot #100088744.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.