Recall Z-1366-2008 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, Inc.
BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL
| Date | Mar 29, 2008 (initiated Feb 14, 2008) |
| Status | Terminated |
| Reason | Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform) |
| Root cause | Process control |
| Action | Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i. |
| Quantity | 254 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS Biomet 3i, Inc., Dec 20, 2007 |