Radiesse — Class II medical device recall Z-2607-2016
Terminated recall by Merz North America, Inc., reported 2016-08-31, distributed nationwide. Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
| Recall number | Z-2607-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merz North America, Inc., Raleigh, NC, United States |
| Recall initiated | 2016-05-20 |
| Classified | 2016-08-19 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,591 units |
| Lot numbers | 100088744 |
| Model numbers | 8063M0K1 |
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.
Reason for recall
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2607-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.