Z-2493-2012 Class II Terminated
FDA device recall Z-2493-2012 was initiated by Zimmer, Inc. on Sep 7, 2012 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Apr 17, 2014). Affected quantity: 60.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2012
- Initiation Date
- Sep 7, 2012
- Termination Date
- Apr 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60
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.
Reason for Recall
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
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.
Code Information
Part 42-5399-018-00, Lots 62034571, 62089766
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2493-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026