Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implanta...
FDA Device Recall #Z-0366-2016 — Class II — October 26, 2015
Recall Summary
| Recall Number | Z-0366-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 26, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merz North America, Inc. |
| Location | Raleigh, NC |
| Product Type | Devices |
| Quantity | 1,616 units |
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.
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.
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.
Lot / Code Information
Lot No. 100083189
Other Recalls from Merz North America, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0401-2021 | Class II | COAPTITE Injectable Implant, injectable, steril... | Sep 30, 2020 |
| Z-2607-2016 | Class II | Radiesse (+) Lidocaine, Injectable Implant 1.5c... | May 20, 2016 |
| Z-0368-2016 | Class II | PROLARYN PLUS Injectable Implant 1.0 cc Plus Ca... | Oct 26, 2015 |
| Z-0367-2016 | Class II | PROLARYN Injectable Implant 1.0 cc Gel, Model N... | Oct 26, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.