Merz North America, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0366-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 26, 2015

Date Posted: December 9, 2015

Recall Number: Z-0366-2016

Event ID: 72585

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,616 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated