Z-1119-2007

Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812...

Name: Z-1119-2007 Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812...
Creator: Biomedicare, Inc.
Published: 2007-06-29
License: https://open.fda.gov/license/

Dentium USA / initiated 2007-06-29 / Terminated / root cause: sterility

FDA source

Biomedicare, Inc. began a recall of Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808... on 2007-06-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1119-2007
Status: Terminated
Initiated: 2007-06-29
Posted: 2007-07-23
Terminated: 2012-07-25
Recalling firm: Dentium USA
Product: Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: sterility
FDA 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 in commerce: 8,844 units
Distribution: In US to AZ, CA, IL, TX & WA. Internationally to Turkey
Product codes and lots: Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814 FX4808W, FX4810W, FX4812W, FX4814W Lot numbers: All distributed product regardless of lot numbers

Product code DZE

K041368Class IIDentium Co., Ltd. ImplantiumDentium Co., Ltd. / cleared 2004-07-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)