Recall Z-2158-2012 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, LLC
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or f
| Date | Aug 8, 2012 (initiated Mar 23, 2012) |
| Status | Terminated |
| Reason | Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant. |
| Root cause | Process control |
| Action | BIOMET 3i sent an Urgent Medical Device Recall letter on March 19, 2012, to all affected customers via email or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers are to return any unopened and unused product for replacement at no cost. In addition, customers should contact Customer Service at 1-800-342-5454 for assistance if they encounter issues with the mating component, or if they have any questions or concerns. Customers are to respond to the notification regardless of whether they have product to return. |
| Quantity | 240 |
| Distribution | Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS Implant Innovations, Inc., Apr 30, 2007 |