Recall Z-0158-2012 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, LLC
"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm(D) X 4mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". Attach an implant to an implant restoration.
| Date | Nov 3, 2011 (initiated Sep 28, 2011) |
| Status | Terminated |
| Reason | On 09/28/2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Conical Angled Abutment, Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for the referenced products may not have been completely sealed prior to shipment. |
| Root cause | Employee error |
| Action | Biomet 3i, LLC sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were asked to inspect their inventory and return any affected product for replacement. A Product Recall Response Form was attached for customers to complete and return via fax to 561-514-6316. Customers are directed to call 1-800-342-5454 for questions regarding this recall. |
| Quantity | 122 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Chile, Italy, Japan, Korea, Spain, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063403 | CONICAL ANGLED ABUTMENT Implant Innovations, Inc., Mar 20, 2007 |