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Recall Observatory FDA recall evidence

Device product

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.

Z-2493-2012

September 07, 2012

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 63125
Status
Terminated
Classification
Class II
Quantity
60
Official record key
device-enforcement:Z-2493-2012

Official wording

Reason: 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

Code information: Part 42-5399-018-00, Lots 62034571, 62089766

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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