Recall Z-0128-2008 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i
Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410
| Date | Jan 17, 2008 (initiated Oct 8, 2007) |
| Status | Terminated |
| Reason | Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform. |
| Root cause | Process control |
| Action | Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i. |
| Quantity | 114 |
| Distribution | Worldwide Distribution - USA, Italy, France, Spain and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060291 | PREFORMANCE TEMPORARY CYLINDER Implant Innovations, Inc., Feb 27, 2006 |