Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only… recallZ-2607-2016 · Merz North America, Inc. · initiated May 20, 2016
Class II Terminated All recalls posted in August 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merz North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2607-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 20, 2016
- Posted by the FDA
- Aug 19, 2016
- Recalling firm
- Merz North America, Inc.
- Quantity
- 1,591 units
- Product code
- LMH
- FDA submissions
- P050052
- 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 description
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.
Code information (models, lots, serial numbers)
Model number: 8063M0K1, Lot #100088744.
Other devices under the same FDA submission
4 devices cleared under P050052 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Radiesse (+) Lidocaine 8063M0K2Merz North America, Inc. · Implant, Dermal, For Aesthetic Use61 reports
- Radiesse Volume Advantage 8071M0K2Merz North America, Inc. · Implant, Dermal, For Aesthetic Use26 reports
- Radiesse (+) Lidocaine1.5cc Injectable Implant 8063M0K1Merz North America, Inc. · Implant, Dermal, For Aesthetic Use12 reports
- Radiesse Volume Advantage 1.5cc 8071M0K1Merz North America, Inc. · Implant, Dermal, For Aesthetic Use8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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