Implant, Dermal, For Aesthetic Use

Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics.

Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.

Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles a

The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conve

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.

Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml.

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 product.

MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY.

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 alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has n

Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical 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) specification. Unfortunately it had been marked as approved, released and shipped.

Revanesse Versa, PN40081

Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.