Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI 10885862093202 Serial Numbers: T31634510, T31788559
- 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:
- Exactech, Inc.
- Reason for Recall:
- The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Product Codes/Lot Numbers:
UDI 10885862093202 Serial Numbers: T31634510, T31788559
Distribution:
Distributed in: OK, VA, FL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1688-2019
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Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.