Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510
- 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:
- A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Product Codes/Lot Numbers:
Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1960-2013
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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