Device product
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.
Z-0198-2015
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 69397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 138 units
- Official record key
device-enforcement:Z-0198-2015
Official wording
Reason: Cleaning process validation failure.
Code information: Part Number 42-5320-079-02 Lot Number 62613813 Part Number 42-5320-071-02 Lot Number 62625781 Part Number 42-5320-075-01 Lot Number 62619031 Part Number 42-5320-075-01 Lot Number 62619040 Part Number 42-5320-079-01 Lot Number 62626696 Part Number 42-5320-071-01 Lot Number 62625790
Distribution pattern: US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.
Derived failure modes
-
Unknown
Cleaning process validation failure.