PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932
- 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:
- The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
Product Codes/Lot Numbers:
Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0367-2016
Related Recalls
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.