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U.S. Department of Health and Human Services

Class 2 Device Recall Biomedicare Implantium Fixtures

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 Class 2 Device Recall Biomedicare Implantium Fixturessee related information
Date Initiated by FirmJune 29, 2007
Date PostedJuly 23, 2007
Recall Status1 Terminated 3 on July 25, 2012
Recall NumberZ-1119-2007
Recall Event ID 38354
510(K)NumberK041368 
Product Classification Endossesous Dental Implant - Product Code DZE
ProductBiomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W
Code Information 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 
FEI Number 3005503242
Recalling Firm/
Manufacturer		 Biomedicare, Inc.
6761 Katella Ave
Cypress CA 90630
For Additional Information ContactDana Rodriguez
714-229-1885
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce8,844 units
DistributionIn US to AZ, CA, IL, TX & WA. Internationally to Turkey
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DZE
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