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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model number: 8063M0K1, Lot #100088744.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Merz North America, Inc.
- Reason for Recall:
- Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Model number: 8063M0K1, Lot #100088744.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2607-2016
Related Recalls
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
Merz North America
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.