Recall Z-2227-2009 ยท NDA Helmet, Cranial, For Protective Use
Biomet 3i, LLC
3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410. Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration.
| Date | Sep 22, 2009 (initiated Dec 11, 2006) |
| Status | Terminated |
| Reason | Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating. |
| Root cause | Nonconforming Material/Component |
| Action | Each of the US customers was contacted by phone. Following the phone contacts, Biomet 3i performed a follow- up of each call with a faxed letter. Each customer was instructed to check their respective inventory for the affected product 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. They were also instructed to return the affected product to Biomet 3i. Contact Biomet 3i, LLC at 1.561.776.6706, if there are any questions. |
| Quantity | 24 |
| Distribution | USA and Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS Biomet 3i, Inc., Dec 20, 2007 |