Z-2607-2016Class II

Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics

Name: Z-2607-2016 Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics
Creator: Merz North America, Inc.
Published: 2016-05-20
License: https://open.fda.gov/license/

Merz North America, Inc. / initiated 2016-05-20 / Terminated / root cause: manufacturing process

FDA source

Merz North America, Inc. began a recall of Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for... on 2016-05-20. FDA classified it as Class II and gives the reason as "Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2607-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-20
Posted: 2016-08-19
Terminated: 2017-05-08
Recalling firm: Merz North America, Inc.
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.
Product code: LMH Implant, Dermal, For Aesthetic Use
Reason for recall: Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Merz sent an Urgent Medical Device Recall Letter dated May 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the enclosed response form and return via fax to (262) 835-3330 or email to [email protected]. For questions contact Merz at (262) 835-3300 ext. 2627.
Quantity in commerce: 1,591 units
Distribution: 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.
Product codes and lots: Model number: 8063M0K1, Lot #100088744.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2607-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2607-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

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)