FDA-Device2014-11-19Class II
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previousl
Zimmer, Inc.
Hazard
Cleaning process validation failure.
Sold states
US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.
Affected count
138 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0198-2015Don't want to check this manually?
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