OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Class I - DangerousWhat Should You Do?
- Check if you have this product: LOT 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043 and 1142210
- 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:
- Osteomed, LLC
- Reason for Recall:
- Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Product Codes/Lot Numbers:
LOT 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043 and 1142210
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2188-2020
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