Recall Z-0171-2012 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 Cornella de Llobregat (Barcelona) Spain***Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The Thread form titanium screws (
| Date | Nov 8, 2011 (initiated Nov 18, 2010) |
| Status | Terminated |
| Reason | The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant. |
| Root cause | Process control |
| Action | The firm sent an Urgent: Medical Device Recall letter, dated November 2010, to notify customers that received the Osseotite Certain Implant (IOSS511) of the problem. The customers were instructed to return the unopened device(s) to Biomet 3i for replacement. If customers notice an issue, they were to contact Customer Service at 1-800-342-5454 for assistance. Customers were to respond via fax and return the implant(s) to BIOMET 3i using the address and incident number provided. Customers with questions or concerns were instructed to contact Mark Mashburn at 561-776-6906. |
| Quantity | 241 |
| Distribution | Worldwide Distribution -- USA , BR, JP, TW, CA, Germany, and Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100724 | OSSEOTITE II MODEL XIFOSSXXX Biomet 3i, Inc., Apr 1, 2011 |