Recall Z-1363-2008 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, Inc.
BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL.
| Date | Feb 7, 2008 |
| Status | Terminated |
| Reason | Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa |
| Root cause | Other |
| Action | Each USA customer was contacted by telephone and then by letter, Urgent Medical Device Recall, dated 2/15/2008, sent by fax. International customers were first contacted by E-mail then by fax letter also. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory for product return. They were also instructed to return the affected product to Biomet 3i. |
| Quantity | 100 |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012911 | 3I LOCATER ABUTMENT SYSTEM Implant Innovations, Inc., Sep 28, 2001 |