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Recall Observatory FDA recall evidence

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

May 20, 2016

Class II

Product summary

Firm
Merz North America, Inc.
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

    reason.no_named_rule · v1.0.0

    Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.