Z-0198-2015 Class II Terminated
FDA device recall Z-0198-2015 was initiated by Zimmer, Inc. on Oct 9, 2014 and is designated Class II. Reason for recall: Cleaning process validation failure. The recall status is terminated (terminated Jun 24, 2015). Affected quantity: 138 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 19, 2014
- Initiation Date
- Oct 9, 2014
- Termination Date
- Jun 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 138 units
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.
Distribution Pattern
US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0198-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026