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Cemented Tibial Drill recallZ-2493-2012 · Zimmer, Inc. · initiated Sep 7, 2012

Class II Terminated All recalls posted in September 2012

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

Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The investigation into the reports that have been received found that the perforations are occurring while using the Cemented Tibial Drill. The perforations have o

FDA root cause category: Device Design

What the company is doing

Zimmer sent an Urgent Medical Device Recall dated August 2012 to distributors via electronic mail and Hospital risk managers and surgeons had notifications hand delivered by sales representatives. The recall notice describes the reason for the recall, emphasizes surgical technique to be used, includes instructions for delivering notifications to surgeons and risk managers, instructions for replacing the affected product, and instructions for returning the affected product. Customers were instructed to locate the affected product and contact their sales representative for replacement. Consignees are asked to fill out the Certificate of Delivery, scan it and send back per the instruction provided.

Recall details

Recall number
Z-2493-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 7, 2012
Posted by the FDA
Sep 28, 2012
Recalling firm
Zimmer, Inc.
Quantity
60
Product code
JWH
FDA submissions
K113369
Distribution
Worldwide Distribution - US Nationwide including the states of: AZ, CA, CO,FL, MN, IL, NJ, NY, OH, OR and the countries of Austrailia, Utd. Arab Emir., France, Germany, India, and Italy.

Product description

Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone.

Code information (models, lots, serial numbers)

Part 42-5399-018-00, Lots 62034571, 62089766

Other devices under the same FDA submission

249 devices cleared under K113369 — 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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