Recall Z-1828-2012 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***cons
| Date | Jun 20, 2012 (initiated Nov 4, 2011) |
| Status | Terminated |
| Reason | On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread. |
| Root cause | Device Design |
| Action | Biomet 3i sent an Urgent: Medical Device Recall letter dated November 04, 2011 via e-mail, facsimile, telephone or postal mail to all consignees affected. The letter identified the affected product, problem and actions to be taken. Each customer was instructed to check their respective inventory for the affected product and return any unused item(s) to Biomet 3i for prompt replacement. For question or concerns contact Biomet 3i at 1-800-342-5454. |
| Quantity | 219 units in total |
| Distribution | Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS Implant Innovations, Inc., Apr 30, 2007 |