OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) INTV-OSFL, Lot Numbers: 11395ZV, 11285ZV, 11574ZV, 11471ZV b) INTV-OSFL-LV, Lot Numbers: 12386ZV
- 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:
- Zavation
- Reason for Recall:
- Products distributed as sterile may not have been adequately sterilized
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
Product Codes/Lot Numbers:
a) INTV-OSFL, Lot Numbers: 11395ZV, 11285ZV, 11574ZV, 11471ZV b) INTV-OSFL-LV, Lot Numbers: 12386ZV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1756-2021
Related Recalls
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized