Cemented Tibial Drill Product Usage: The cemented tibial drill is… — Class II medical device recall Z-2493-2012
Terminated recall by Zimmer, Inc., reported 2012-10-10, distributed nationwide. Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due
| Recall number | Z-2493-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-09-07 |
| Classified | 2012-09-28 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2014-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FR, IN, IT |
| Quantity | 60 |
| Lot numbers | 62034571, 62089766 |
| Model numbers | 42-5399-018-00, 62034571, 62089766 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2493-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.