FDA Devices recall · Reported October 10, 2012
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 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….
- Moderate
- severity level
- 60 units
- affected scope
- Class II
- classification
- October 10, 2012
- reported
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.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
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
Recall Profile
| 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.
- Check the recall number (Z-2493-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026