Recall Z-0853-2017 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, LLC
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
| Date | Sep 14, 2016 |
| Status | Terminated |
| Reason | A limited number of product pouches may not have been sealed during packaging. |
| Root cause | Employee error |
| Action | BIOMET 3i will conduct this recall with Dentists and Health Care Professionals. Notices will be sent via a carrier with a traceable method of delivery by BIOMET 3i team members. " All dentists and health care professionals will be notified via courier: - Dentists and health care professionals will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their control. - Dentists and health care professionals will return on-hand product to BIOMET 3i via a courier agency and ensure all of their products are accounted |
| Quantity | 191 |
| Distribution | Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION Biomet 3i, Inc., Nov 30, 2009 |