Recall Z-1119-2007 ยท DZE Implant, Endosseous, Root-Form
Biomedicare, Inc.
Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W
| Date | Jul 23, 2007 (initiated Jun 29, 2007) |
| Status | Terminated |
| Reason | Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures distributed to date. |
| Root cause | Other |
| Action | The firm initiated the recall notification with telephone calls to all consignees on 06/30/2007. Recall letters with attached Recall Response Form were mailed to all customers on 06/30/2007 by certified US mail. Customers were asked to examine their inventory and immediately remove all Implantium Fixtures from their inventory and quarantine until arrangements could be made for product return. |
| Quantity | 8,844 units |
| Distribution | In US to AZ, CA, IL, TX & WA. Internationally to Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041368 | DENTIUM CO., LTD. IMPLANTIUM Dentium Co., Ltd., Jul 29, 2004 |