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Recall Observatory FDA recall evidence

Device product

Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.

Z-0366-2016

October 26, 2015

Class II

Product summary

Firm
Merz North America, Inc.
Event
Event 72585
Status
Terminated
Classification
Class II
Quantity
1,616 units
Official record key
device-enforcement:Z-0366-2016

Official wording

Reason: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

Code information: Lot No. 100083189

Distribution pattern: 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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label is incorrect