Recall Z-2140-2019 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, LLC
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
| Date | Feb 26, 2019 |
| Status | Terminated |
| Reason | During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop. |
| Root cause | Process control |
| Action | The firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral. |
| Quantity | 3 units |
| Distribution | Nationwide and Puerto Rico, Canada, and Australia |
| FDA record | Open on fda.gov |