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SCULPTRA
SAIMA GLOBAL FARMA S.L. · Model 2 Vials · UDI-DI 08437027710117
LMH
Prescription
0
510(k) clearances
22,781
Adverse events (14 deaths)
7
Recalls
35
Facilities
Description
SCULPTRA is a sterile, injectable, biocompatible, biodegradable material that is made of poly-L-lactic acid (a synthetic polymer), sodium carboxymethylcellulose and non-pyrogenic mannitol. SCULPTRA is indicated for use in immune-competent subjects for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles, and correction of fine lines and wrinkles in the cheek region. It is also indicated in people with HIV-associated lipoatrophy for restoration and/or correction of the signs of facial fat loss.
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.