Severity
Moderate
FDA Devices recall · Reported October 10, 2012
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 co…
Zimmer, Inc. recalled Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the… - a moderate-severity action.
Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the… was recalled by Zimmer, Inc. in October 10, 2012. Reason: Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System du…. Check the official notice for the remedy. Verify recall #Z-2493-2012 with the FDA Devices before acting.
The recall
Zimmer, Inc. issued this moderate-severity FDA Devices recall-Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System du….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2493-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2493-2012) was formally reported on October 10, 2012, with the manufacturer initiating the action on September 7, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 60.
The documented reason for this recall is: 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 t… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
60
Related Recalls
6
3 from same agency
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.
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
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2493-2012 |
| Date reported | October 10, 2012 |
| Date initiated | September 7, 2012 |
| Recalling firm | Zimmer, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 10, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.