CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 1228885 1229618 1230155 1230308
- 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:
- Biomet 3i, LLC
- Reason for Recall:
- Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
Product Codes/Lot Numbers:
Lot Numbers: 1228885 1229618 1230155 1230308
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1367-2020
Related Recalls
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient