Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308,
FDA device recall Z-1119-2007 · posted 2007-07-23 · Terminated
Recall details
- Recalling firm
- Biomedicare, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 8,844 units
- Distribution
- In US to AZ, CA, IL, TX & WA. Internationally to Turkey
- Date initiated
- 2007-06-29
- Date posted
- 2007-07-23
- Date terminated
- 2012-07-25
- Location
- Cypress, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DENTIUM CO., LTD. IMPLANTIUM (K041368) | Dentium Co., Ltd. | 2004-07-29 |