Reported Dec 26, 2012 · Terminated
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with
- severe knee pain and disability due too 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
- Lot codes and dates
- Part Number 42-5320-064-01 TIBIA SIZE C
- LEFT Lots
62018336620183376203338062051020620607396206841362076438620797406209136062117665and 77001708Part Number 42-5320-064-02
- TIBIA SIZE C RIGHT Lot
62018338620183396203338362051021620607406206074262068415620764396207974162091361and 62117666
- Amount recalled
- 318
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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