Z-0366-2016Class II

Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the...

Name: Z-0366-2016 Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the...
Creator: Merz North America, Inc.
Published: 2015-10-26
License: https://open.fda.gov/license/

Merz North America, Inc. / initiated 2015-10-26 / Terminated / root cause: labeling and UDI

FDA source

Merz North America, Inc. began a recall of Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles... on 2015-10-26. FDA classified it as Class II and gives the reason as "The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0366-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-26
Posted: 2015-12-03
Terminated: 2017-05-08
Recalling firm: Merz North America, Inc.
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.
Product code: LMH Implant, Dermal, For Aesthetic Use
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letters dated 11/4/2015 were sent to customers with tracking and delivery confirmation. The letter informs the customer that they may continue to safely use the affected product by referring to the USE BEFORE date.
Quantity in commerce: 1,616 units
Distribution: 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.
Product codes and lots: Lot No. 100083189

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0366-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0366-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-03

Product code LMH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)