Restylane Refyne
Q-Med AB · Model Gel 1.0 ml syringe - demo · UDI-DI 07331689112559
LMH
Prescription
0
510(k) clearances
22,594
Adverse events (14 deaths)
7
Recalls
35
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-15 | Prollenium Medical Technologies Inc. | Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months. |
| 2016-05-20 | Merz North America, Inc. | Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. |
| 2015-10-26 | Merz North America, Inc. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
| 2015-02-26 | Orthovita, Inc., dBA Stryker Orthobiologics. | Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time. |
| 2013-08-07 | Enhancement Medical, LLC | Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of p |
| 2011-08-18 | Merz Aesthetics, Inc. | There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be a |
| 2011-04-06 | Merz Aesthetics, Inc. | Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specificat |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.