Persona The Personalized Knee System recall
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated…
Why was Persona The Personalized Knee System 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number 42-5320-064-01 TIBIA SIZE C, LEFT Lots: 62018336, 62018337, 62033380, 62051020, 62060739, 62068413, 62076438, 62079740, 62091360, 62117665, and 77001708, Part Number 42-5320-064-02 TIBIA SIZE C RIGHT Lot: 62018338, 62018339, 62033383, 62051021, 62060740, 62060742, 62068415, 62076439, 62079741, 62091361,and 62117666
- Product
- Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 318
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
- Recall date
- December 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)