CLASS II Device recall · Reported 26 Dec 2012 · FDA Enforcement Report
Persona, The Personalized Knee System,Tibial Drill recalled by Zimmer
Zimmer is recalling Persona, The Personalized Knee System,Tibial Drill, Cemented Diameter, Nonsterile This, distributed nationwide in the US. The recall was initiated on 14 Nov 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0545-2013
- FDA event ID
- 63690
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2012
- FDA classified
- 18 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 14 Nov 2012 | Recall initiated by company | |
| 18 Dec 2012 | Classified by FDA | +34 days |
| 26 Dec 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.
Where it was distributed
Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
Questions about this recall
Is Persona, The Personalized Knee System,Tibial Drill, Cemented Diameter, Nonsterile This recalled?
Yes. Zimmer recalled Persona, The Personalized Knee System,Tibial Drill, Cemented Diameter, Nonsterile This on 14 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0545-2013.
Why was it recalled?
All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening
Which lots are affected?
Part Number 42-5399-018-00,Lot 77001868
Where was it sold?
Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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