Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W
FDA Recall Z-1119-2007 · Posted 2007-07-23
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Recalling FirmBiomedicare, Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2007-06-29
Date Terminated2012-07-25
Product Quantity8,844 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
In US to AZ, CA, IL, TX & WA. Internationally to Turkey
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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