RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial #'s: 30303308, 30303321, 30303327, 30303340, 3034313, 30304314, 30304330, 30401686, 30401699, 30401714, 30401721, 30401723, 30401730, 30401732, 30401735, 3041741, 30401746, 30401750, 30718244, 30718441, 30718442, 30718448, and 30718449.
- 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:
- RTI Surgical, Inc.
- Reason for Recall:
- Incorrect instructions for use (IFU) included.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Product Codes/Lot Numbers:
Serial #'s: 30303308, 30303321, 30303327, 30303340, 3034313, 30304314, 30304330, 30401686, 30401699, 30401714, 30401721, 30401723, 30401730, 30401732, 30401735, 3041741, 30401746, 30401750, 30718244, 30718441, 30718442, 30718448, and 30718449.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1441-2017
Related Recalls
RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.
As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a s