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Biomedicare Implantium Fixtures, Model numbers : FX3408… recallZ-1119-2007 · Biomedicare, Inc. · initiated Jun 29, 2007

Terminated All recalls posted in July 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomedicare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1119-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 29, 2007
Posted by the FDA
Jul 23, 2007
Recalling firm
Biomedicare, Inc.
Quantity
8,844 units
Product code
DZE
FDA submissions
K041368
Distribution
In US to AZ, CA, IL, TX & WA. Internationally to Turkey

Product description

Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

15 devices cleared under K041368 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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