| | Class 2 Recall
Persona, The Personalized Knee System |  |
| Date Posted |
December 18, 2012 |
| Recall Number |
Z-0549-2013 |
| Product |
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile,
This device is used with the Persona Knee System for patients with severe knee pain and disability due to: 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. |
| Code Information |
Part Number 42-5399-022-07, Lot 62032102, 62087056, 62162437
|
Recalling Firm/
Manufacturer |
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746 |
| For Additional Information Contact |
Stephen White
574-372-4807
|
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
|
| Action |
Zimmer sent distributors beginning the week of November 14, 2012, E-mail information requesting all equipment be collected in distributors office before shipment back to Zimmer and replacement. A telephone conference discussing the recall and amended surgical technique was held the week of November 14, 2012, and Urgent Recall notices were sent to Distributors describing the devices; risks; updated surgical technique with directions to hand deliver surgeon/risk manager letters to all affected surgeons and risk managers in hospitals receiving the product. The notices included directions to remove all affected product and ensure risk manager letter is provided. The letter stated a Zimmer Inc. employee will conduct onsite reconciliation and asked return of distribution Spreadsheet to CorporateQuality.Postmarket@zimmer.com within 24 hours of receiving notification. Product is to be returned with certificate of sterilization to Zimmer Product Service Department 1777 West Center St. Warsaw, IN 46580 or Zimmer International Logistics, Eschbach Germany for International Accounts.
For questions regarding this recall call 574-372-4807. |
| Quantity in Commerce |
92 |
| Distribution |
Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe. |
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