The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Merz North America
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Class I - Dangerous
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Class I - Dangerous
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.