Recall Z-0959-2007 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i
Biomet 3 i, Disposable Twist Drills, Model Number DT2715.
| Date | Jun 19, 2007 (initiated May 14, 2007) |
| Status | Terminated |
| Reason | The depth indicator laser line markings on the drills are too faint for clinicians to read during use. |
| Root cause | Other |
| Action | Each domestic consignee was contacted on 5/14/07 by phone using a prepared script. A follow up letter was then faxed to each consignee. International consignees were contacted by email followed by a faxed letter. Each consignee was instructed to examine their inventory for the recalled product. They were requested to complete and fax back a response form to Biomet and to return any affected product. |
| Quantity | 147 |
| Distribution | World Wide: USA states including: NY, MA, MD, NJ, IL, DE, RI, CA, MI, VA, KS and fL. Internationally to Brazil, Germany, France, Great Briton Japan, Greece and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.