Merz Aesthetics GmbH
Country not established FDA establishment FEI 3022121566
- Devices
- 0
- Registrations
- FDA
- FDA recalls
- 3
Company details
- FDA FEI number
- 3022121566
- Address
- Eckenheimer Landstrasse 100, Frankfurt Am Main Hesse
FDA recalls
2011
- 16 Dec 2011 Z-0694-2012 Unclassified (pre-2012) Terminated Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 mm in size instead of 27G x 38 mm. Length of the cannula is a matter of user preference and is unlikely to impact patient safety.
- 18 Aug 2011 Z-0145-2012 Unclassified (pre-2012) Terminated 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
Full distribution text
- 6 Apr 2011 Z-2221-2011 Unclassified (pre-2012) Terminated 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.