Recall Z-2607-2016— Merz North America, Inc.
Class II · Terminated
Class II FDA medical device recall by Merz North America, Inc., initiated 2016-05-20, terminated 2017-05-08. Product: Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.. Reason: Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle..
- Recalling firm
- Merz North America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-20
- Terminated
- 2017-05-08
- Firm location
- Raleigh, NC, United States
Product description
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
Reason for recall
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.