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Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx… recallZ-0499-2010 · Zimmer Inc. · initiated Nov 6, 2009

Terminated All recalls posted in December 2009

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 Zimmer 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

The devices may not meet specifications, which may result in fracturing during tightening of the component.

FDA root cause category: Process control

What the company is doing

User accounts were notified of the issue by phone on or about 11/6/09. Clinicians were requested to schedule a follow-up appointment and to remove and replace the recalled components for any patients who had this device placed without fracturing during the procedure. Questions are directed to the company at 1-800-854-7019.

Recall details

Recall number
Z-0499-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 6, 2009
Posted by the FDA
Dec 10, 2009
Recalling firm
Zimmer Inc.
Quantity
738
Product code
DZE
FDA submissions
K061410
Distribution
Ohio, Canada and France.

Product description

Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.

Code information (models, lots, serial numbers)

Lots 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224.

Other devices under the same FDA submission

1 device cleared under K061410 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page