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RESTYLANE LYFT WITH LIDOCAINE

SAIMA GLOBAL FARMA S.L. · Model Gel 1 mL Syringe · UDI-DI 08437027710087

LMH PKY Prescription

510(k) clearances

22,781

Adverse events (14 deaths)

Recalls

Facilities

Description

RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin with the additon of lidocaine hydrochloride 0.3%. It is indicated in patients over the age of 21 for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds; for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies; and for injection into the subcutaneous plane in the dorsal hand to correct volume deficit.

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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Data 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.