PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 19, 2014 Initiated: October 9, 2014 #Z-0198-2015

Product Description

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.

Reason for Recall

Cleaning process validation failure.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
138 units
Distribution
US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Zimmer, Inc.. Units affected: 138 units.
Why was this product recalled? ▼
Cleaning process validation failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2014. Severity: Moderate. Recall number: Z-0198-2015.

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