Z-2493-2012Class II

Cemented Tibial Drill

Name: Z-2493-2012 Cemented Tibial Drill
Creator: Zimmer, Inc.
Published: 2012-09-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-09-07 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of 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... on 2012-09-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2493-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-07
Posted: 2012-09-28
Terminated: 2014-04-17
Recalling firm: Zimmer GmbH
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 60
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 codes and lots: Part 42-5399-018-00, Lots 62034571, 62089766

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2493-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2493-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28

Product code JWH

K113369Class IIZimmer Persona Knee SystemZimmer, Inc. / cleared 2012-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)