Recall Z-0810-2010 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures with one or more implants, limited interarch distance, angle correction with up to 40 degrees betw
| Date | Feb 22, 2010 (initiated Nov 23, 2009) |
| Status | Terminated |
| Reason | Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility. |
| Root cause | Process control |
| Action | Each US customer will be contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i will perform a follow-up of each call with a faxed letter. The Urgent: Medical Device Recall letter, dated 11/23/2009, identified the affected product and asked customers to return unused product for replacement. The letter also explained the clinical implications and asked customers to respond with the attached response fax and then return the abutment(s) to BIOMET 3i. Questions or concerns can be directed to Kelly Taylor at 561-776-6906. |
| Quantity | 97 |
| Distribution | Worldwide Distribution -- USA, Middle East, Italy, Europe, and Greece. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012911 | 3I LOCATER ABUTMENT SYSTEM Implant Innovations, Inc., Sep 28, 2001 |